Contiflo XL 400 Micrograms Capsules

Contiflo XL 400 Micrograms Capsules

Tamsulosin Hydrochloride

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

 

What is in this leaflet

1 What Contiflo XL is and what it is used for

2 What you need to know before you take Contiflo XL

3 How to take Contiflo XL

4 Possible side effects

5 How to store Contiflo XL

6. Contents of the pack and other information

 

1 What Contiflo XL is and what it is used for

The active ingredient in Contiflo XL is tamsulosin. This is a selective 1A1D-adrenoceptor antagonist. It reduces tension of the smooth muscles in the prostate and the urethra, enabling urine to pass more readily through the urethra and facilitating urination. In addition, it diminishes sensations of urge.

Contiflo XL is used in men for the treatment of the complaints of the lower urinary tract associated with an enlarged prostatic gland (benign prostatic hyperplasia) These complaints may include difficulty urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well as during the day.

 

2 What you need to know before you take Contiflo XL

Do not take Contiflo XL:

– If you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of the soft tissues of the body (e.g. the throat or tongue), difficult breathing and/or itching and rash (angioedema).

– If you suffer from severe liver problems.

– If you suffer from fainting due to reduced blood pressure when changing posture (going to sit or stand up).

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Contiflo XL.

– Periodic medical examinations are necessary to monitor the development of the condition you are being treated for.

– Rarely, fainting can occur during the use of Contiflo XL as with other medicinal products of this type.

At the first signs of dizziness or weakness you should sit or lie down until they have disappeared.

– If you suffer from severe kidney problems, tell your doctor.

– If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract), please inform your eye specialist that you have previously used, are using, or are planning to use Contiflo XL. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens.

 

Children

Do not give this medicine to children or adolescent under 18 years because it does not work in this population.

 

Other medicines and Contiflo XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Contiflo XL together with other medicines from the same class (α1-adrenoceptor antagonists) may cause an unwanted decrease in blood pressure.

It is especially important to inform your doctor if you are being treated at the same time with medicines that may decrease the removal of Contiflo XL from the body (for example, ketoconazole, erythromycin).

 

Contiflo XL with food, drink or alcohol

Contiflo XL must be taken after breakfast or the first meal of the day.

 

Pregnancy, breast-feeding and fertility

This section is not relevant, because Contiflo XL is not indicated for use in women. Impaired sexual functions in males have been reported with Contiflo XL.

 

Driving and using machines

There is no evidence that Contiflo XL affects the ability to drive or to operate machinery or equipment.

However, you should bear in mind that dizziness can occur, in which case you should not undertake activities that require attentiveness.

 

Contiflo XL contains sunset yellow, azorubine and ponceau 4R

Allergic reactions may occur due to the presence of colouring agents used in this product: sunset yellow (E110), azorubine (E122) and ponceau 4R (E124).

 

3 How to take Contiflo XL

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dosage is one capsule per day to be taken after breakfast or the first meal of each day. The capsule must be swallowed whole and not be crunched or chewed. Usually, Contiflo XL is prescribed for long periods of time. The effects on the bladder and on urination are maintained during long-term treatment with Contiflo XL.

 

If you take more Contiflo XL than you should

Taking too many capsules of Contiflo XL may lead to an unwanted decrease in blood pressure and an increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken too much Contiflo XL.

 

If you forget to take Contiflo XL

You may take your daily Contiflo XL later the same day if you have forgotten to take it as recommended. If you have missed a day, just continue to take your daily capsule as prescribed. Do not take a double dose to make up for a forgotten capsule.

 

If you stop taking Contiflo XL

When treatment with Contiflo XL is stopped prematurely, your original complaints may return. Therefore use Contiflo XL as long as your doctor prescribes, even if your complaints have disappeared already. Always consult your doctor, if you consider stopping this therapy. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Common (less than 1 in 10, more than 1 in 100 (1-10%)):

Dizziness, particularly when going to sit or stand up.

Ejaculation disorders.

Retrograde ejaculation; this means that semen does not leave the body via the urethra, but instead goes into the bladder. This phenomenon is harmless.

Ejaculation failure.

 

Uncommon (more than 1 in 1000, less than 1 in 100 (0.1-1%)):

Headache, palpitations (the heart beats more rapidly than normal and it is also noticeable), reduced blood pressure e.g. when getting up quickly from a seating or lying position sometimes associated with dizziness; runny or blocked nose (rhinitis), diarrhoea, feeling sick and vomiting, constipation, weakness (asthenia), rashes, itching and hives (urticaria).

 

Rare (more than 1 in 10,000, less than 1 in 1000 (0.01-0.1%)):

Faintness and sudden local swelling of the soft tissues of the body (e.g. the throat or tongue) difficult breathing and / or itching and rash, often as an allergic reaction (angioedema).

 

Very rare (less than 1 in 10,000 (<0.01%):

Priapism (painful prolonged unwanted erection for which immediate medical treatment is required). Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).

 

Not known (frequency cannot be estimated based on available data):

Vision blurred, visual impairment.

Nose bleed.

Severe condition of the skin that may affect the mouth and other parts of the body.

Skin disease.

Dry mouth.

Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea).

If you are undergoing eye surgery because of cloudiness of the lens (cataract) and are already taking or have previously taken Contiflo XL, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.

 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

 

5 How to store Contiflo XL

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

 

6 Contents of the pack and other information

What Contiflo XL contains

The active substance is tamsulosin hydrochloride. One prolonged release capsule contains 400 micrograms of tamsulosin hydrochloride.

The other ingredients are: capsule contents: cellulose microcrystalline PH 101, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion, sodium hydroxide, triacetin, titanium dioxide (E171), purified talc.

Capsule body: gelatine, sunset yellow, ponceau 4R (E124), quinoline yellow (E104), brilliant blue (E133), titanium dioxide (E171).

Cap composition: gelatine, yellow iron oxide (E172), brilliant blue (E133), azorubine (E122), titanium dioxide (E171).

Printing ink: shellac, black Iron oxide (E172), potassium Hydroxide.

 

What Contiflo XL looks like and contents of the pack

Contiflo XL 400 micrograms prolonged release capsules comprise of Brown cap/Orange body of size ‘2’ imprinted with ‘R’ on cap and ‘TSN400’ on body in black edible ink containing white to off-white granules.

Packs of 1, 2, 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 200 prolonged release capsules. Not all pack sizes may be marketed.

 

Marketing Authorisation Holder and Manufacturer

Ranbaxy (UK) Limited

5th floor, Hyde Park, Hayes 3

11 Millington Road

Hayes, UB3 4AZ

United Kingdom

 

Manufacturers

Sun Pharmaceutical Industries Europe B.V.

Polaris avenue 87
2132 JH Hoofddorp

The Netherlands

 

Terapia, S. A.

124, Fabricii Street,

Zipe Code 400632,

Cluj Napoca, Cluj

Romania

 

This leaflet was last revised in October 2016.

Teva Finasteride 5 mg Film Coated Tablets

FINASTERIDE 5 mg Film-coated Tablets
Finasteride

Package leaflet: Information for the user

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it onto others. It may harm them even, if their signs of illness are the same as yours.

• If you get any side effect talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

 

What is in this leaflet

1. What Finasteride is and what It is used for

2. What you need to know before you take Finasteride

3.How to take Finasteride

4. Possible side effects

5. How to store Finasteride

6. Contents of the pack and other information

 

1 What Finasteride is and what it is used for

Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men.

Finasteride is used in the treatment and control of benign enlargement of the prostate (benign prostatic hyperplasia – BPH). It causes regression of the enlarged prostate, improves urinary flow and symptoms caused by BPH, and reduces the risk of acute urinary retention and the need for surgery.

 

2 What you need to know before you take Finasteride

Do NOT take Finasteride

– If you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).

– If you are a woman (see also under “Pregnancy and breast-feeding”)

– If you are a child.

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Finasteride.

– If you have a large amount of residual urine and/or severely reduced urinary flow. If this is the case, you should be closely monitored for narrowing of the urinary tract.

– If you have a reduced liver function. The finasteride plasma level may be increased in these patients.

Speak to your doctor if any of the above applies to you now or in the past.

You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such as breast cancer.

A clinical examination (including digital rectal examination) and a determination of prostate-specific-antigen (PSA) in serum should be carried out prior to initiating therapy with finasteride and during treatment.

 

Other medicines and Finasteride

No significant drug interactions have been identified.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

 

Pregnancy and breast-feeding

Finasteride is only intended for men.

Women who are pregnant or may become pregnant should not handle broken or crushed Finastende tablets. If finasteride is absorbed through the skin or taken by mouth by a woman pregnant with a male foetus, the child may be born with malformed genital organs. The tablets are film-coated, which prevents contact with finasteride provided the tablets are not broken or crushed.

 

Driving and using machines

There are no data which suggest that Finasteride affects the ability to drive or use machines.

 

Finasteride contains lactose

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Please consult your doctor before taking Finasteride 5 mg if you know that you suffer from a sugar intolerance.

 

3 How to take Finasteride

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 1 tablet daily (equivalent to 5 mg finasteride).

The film-coated tablets can either be taken on an empty stomach or with a meal. The film-coated tablets should be swallowed whole and should not be divided or crushed.

Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved.

Your doctor will tell you how long you should continue to take Finasteride 5 mg. Do not interrupt treatment early or the symptoms may come back.

 

Patients with hepatic impairment

There is no experience of the use of Finasteride 5 mg in patients with restricted liver function (see also “Take special care with Finasteride 5 mg”).

 

Patients with renal impairment

No dosage adjustment is required. The use of Finasteride 5 mg in patients who have to undergo haemodialysis has not been investigated to date.

Older people

No dosage adjustment is required.

Please speak to your doctor or pharmacist if you feel that the effect of Finasteride 5 mg is too strong or too weak.

If you take more Finasteride than you should

If you take more Finasteride 5 mg than you should or if children have been taking medicine by accident please notify your doctor immediately.

If you forget to take Finasteride

If you forget to take a dose of Finasteride 5 mg, you can take it as soon as you remember unless it is almost time for the ne dose, in which case you should continue with your medication as prescribed. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not every body gets them.

Allergic reactions (frequency cannot be estimated from the available data)

Stop using Finasteride and immediately contact a doctor if you experience allergic reactions and any of the following symptoms (angioedema): swelling of face, tongue or throat; difficulty swallowing; lumps under the skin (hives) and breathing difficulties.

Other possible side effects during treatment:

Common: may affect up to 1 in 10 people

– You may be unable to have an erection (impotence).

– You may have less desire to have sex.

These side effects above may disappear after a while if you continue taking Finasteride.

If not, they usually resolve after stopping Finasteride.

– You may have a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function.
Uncommon: may affect up to 1 in 100 people.

– Skin rashes and itching,

– Sleepiness.

– Breast swelling or tenderness.

– Problems with ejaculation.

Not known: (frequency cannot be estimated from the available data).

– Palpitations (feeling your heartbeat).

– Changes in the way your liver is working, which can be shown by a blood test.

– Pain in your testicles.

– Male infertility and/or poor quality of semen.

– Depression.

– Decrease in sex drive that may continue after stopping the medication.

– Problems with erection that may continue after stopping the medication.

You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement or nipple discharge as these may be signs of a serious condition, such as breast cancer.

Finasteride may affect the result of PSA-laboratory test.

 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

 

5 How to store Finasteride

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the container and the outer packaging after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

 

6 Contents of the pack and other information

What Finasteride contains

– The active substance is finasteride. One film-coated tablet contains 5 mg finasteride.

– The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, pregelatinised starch (maize), povidone K30, sodium starch glycolate (type A), magnesium stearate, sodium laurilsulfate. The tablet coating Opadry 03G20795 Blue contains (hypromellose, (E464), titanium dioxide (E171), macrogol 6000, macrogol 400, indigo carmine lake (E132).

What Finastende looks like and contents of the pack

Finasteride 5 mg film-coated tablets are blue, capsule shaped tablets, with the inscription “FNT5” on one side and plain on the other.

Blister packs PVC/PVDC/Aluminium: 10, 14, 15, 20, 28, 30, 50, 50×1, 56, 60, 98, 100×1 tablets.

Not all pack sizes may be marketed.

 

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is TEVA

UK Limited, Eastbourne BN22 9AG and the

Company responsible or manufacture:

Teva Pharmaceutical Works Private Limited

Pallagi ut 13. Debrecen H-4042 Hungary

 

This leaflet was revised in April 2016

PL00289/1024

Lutamide Flutamide Tablets

Lutamide®
Flutamide 250mg Tablets

 

COMPOSITION

Each uncoated tablet contains:

Flutamide USP 250mg.

Excipients Q.S.

 

INDICATIONS

LUTAMIDE is indicated in the treatment of advanced prostatic cancer (D2) as initial treatment in combination with a luteinizing hormone-releasing hormone (LHRH) agonist, as adjunctive therapy in patients already receiving LHRH agonist, in surgically castrated patients and in patients who have not responded or have become refractory to or who cannot tolerate other hormonal manipulation.

LUTAMIDE is also indicated in combination with LHRH agonists for the management of locally confined B2-C2 (T2b-T4) prostate carcinoma as initial therapy; bulky primary tumors confined to the prostate (stage B2 or T2b) or extending beyond the capsule (stage C or T3-T4), with or without pelvic node involvement.

 

DOSAGE AND ADMINISTRATION

The patient should not interrupt or alter the dosage regimen without consulting the clinician.

The recommended dosage is 250mg three times daily at 8-hour intervals.

In combination with an LHRH agonist, it is recommended that LUTAMIDE therapy should be started 3 days prior to initiation of the LHRH agonist, to reduce the flare reaction. During radiation therapy, administration of both LUTAMIDE and LHRH agonist should begin 8 weeks prior and continue through the course of radiation (usually about 8 weeks), i.e. a total of about 16 weeks.

 

CONTRAINDICATIONS

Hypersensitivity to flutamide or any component of this preparation.

 

WARNINGS AND PRECAUTIONS

Drug interactions

On concomitant therapy with anticoagulants, adjustment of the initiating dose or maintenance anticoagulant dose may be necessary because increases in prothrombin time have been noted. Close monitoring of prothrombin time is recommended. Avoid concomitant administration of potentially hepatotoxic drugs. Cases of increased theophylline plasma concentrations have been reported in patients receiving concomitant theophylline and flutamide. Theophylline is primarily metabolized by CYP 1A2 which is the primary enzyme responsible for the conversion of flutamide to its active agent 2-hydroxyflutamide.

 

Pregnancy

LUTAMIDE is indicated only for use in male patients. There is no data on pregnant women.

 

Lactation

LUTAMIDE is indicated only for use in male patients. There is no data on lactating women.

 

Paediatric use

Flutamide has not been studied in paediatric subjects.

 

UNDESIRABLE EFFECTS

Most frequent side-effects are gynaecomastia and breast tenderness, some times galactorrhoea. These disappear on stopping treatment.

Less frequent adverse reactions are diarrhoea, nausea, vomiting, insomnia, tiredness, transient abnormal liver function and hepatitis. Decreased libido, upset stomach, anorexia, ulcer-like pain, heartburn, constipation, oedema, ecchymosis, pruritus, lupus-like syndrome, headache, dizziness, weakness, malaise, blurred vision and reduced sperm counts have been reported rarely.

Rarely anaemia, leukopenia, anorexia, jaundice, hypertension, central nervous system adverse events and thrombocytopenia may be observed.

Additional adverse experiences: Very rarely, the following have been reported:
haemolytic anaemia, methaemoglobinaemia, photosensitivity reactions, cholestatic jaundice, hepatic encephalopathy and hepatic necrosis. The hepatic conditions were usually reversible after stopping treatment.

 

OVERDOSAGE

The single dose of flutamide associated with symptoms of overdose or considered life threatening has not been established. Since flutamide is highly protein bound, dialysis may not be of any use as treatment for overdose. Gastric lavage may be considered.

 

PACKAGING IN FORMATION

5 x 4 x 21 Tablets in Blister pack.

 

Manufactured by

WEST COAST PHARMACEUTICAL WORKS LTD.

FP No.: 17, 16/5, Meldi Estate, B/S Medi Mata Temple,

NR Gota Railway Crossing, Gota, Ahmedabad-382481, India

 

Manufactured for

Stallion LABORATORIES PVT. LTD.

C-1B, 305/2 & 3, G.I.D.C. Kerala (Bavla) Dist: Ahmedabad-382 220. Gujarat.