Document: leaflet MAH GENERIC_PL 20338-0020 change

• leaflet MAH BRAND_PL 20338-0020
• leaflet MAH GENERIC_PL 20338-0020

---

PACKAGE LEAFLET: INFORMATION FOR THE USER

RANITIDINE 75 mg TABLETS

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Ranitidine 75 mg Tablets carefully to get the best results from it.

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

•    Ask your pharmacist if you need more information or advice.

•    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.

•    You must talk to a doctor if you do not feel better, or if you feel worse, after 6 days.

In this leaflet:

1.    What Ranitidine Tablets are and what they are used for

2.    Before you take Ranitidine Tablets

3.    How to take Ranitidine Tablets

4.    Possible side effects

5.    How to store Ranitidine Tablets

6.    Further information

The name of your medicine is Ranitidine 75 mg Tablets, it will be referred to as Ranitidine Tablets in the rest of this leaflet. It contains the active ingredient called Ranitidine Hydrochloride.

Ranitidine belongs to a group of medicines called H2-antagonists. It works by preventing your stomach from producing too much acid and its effects last for up to 12 hours.

The tablets are used to relieve the burning sensation in the stomach and chest caused by heartburn, indigestion, acid indigestion and hyperacidity (too much acid).

Do not take Ranitidine Tablets: if you have an allergy to Ranitidine or to any of the ingredients listed at the end of this leaflet.

If you are not sure whether you should start taking Ranitidine Tablets, talk to your doctor.

Ranitidine Tablets are not recommended for children under 16 years old.

You must tell your doctor or pharmacist if you:

•    have been told by a doctor that you have an ulcer in the stomach or small intestine (lower part of your stomach)

•    have kidney and/or liver problems

•    are under regular medical supervision for other reasons

•    are suffering from any other illness or taking medications either prescribed by a physician or prescribed by yourself

•    have lost weight unintentionally linked with symptoms of indigestion

•    you have difficulty swallowing or persistent stomach pain

•    have breathing problems

•    have a weak immune system

•    suffer from diabetes

•    are middle-aged or elderly with new or recently changed symptoms of indigestion

•    are taking non-steroidal anti-inflammatory painkillers especially the elderly (NSAIDs, such as Aspirin)

•    have the rare condition called porphyria.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

•    lidocaine, a local anaesthetic

•    propranolol, procainamide or n-acetylprocainamide, for heart problems

•    diazepam, for worry or anxiety problems

•    phenytoin, for epilepsy

•    theophylline, for breathing problems ( asthma )

•    warfarin, for thinning your blood

•    glipizide, for lowering blood glucose

•    atazanavir or delaviridine, for treating HIV infection

•    triazolam, for insomnia or midazolam

•    gefitnib, for lung cancer

•    ketoconazole, an anti fungal medicine, sometimes used for treating thrush

•    sucralfate, an ulcer healing drug.

Midazolam is a medicine that may be given to you just before you have an operation. Tell the doctor you are taking Ranitidine before your operation in case he or she wants to give you midazolam.

Pregnancy and breast-feeding

Ranitidine should only be taken during pregnancy or whilst breast-feeding if considered essential by your doctor.

If you are pregnant or breast-feeding or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine should not affect your ability to drive or use machines although it may cause dizziness or blurred vision in some people; do not drive or use machines if you are affected.

Adults and children over 16 years of age:

Swallow one tablet (75 mg of Ranitidine) whole with water as soon as symptoms appear. If symptoms are not controlled or return within one hour, swallow another tablet.

Do not take more than 2 tablets (150mg of Ranitidine) in 24 hours.

Medical attention should be sought if symptoms worsen.

Do not take tablets for more than 6 days without the advice of a pharmacist or doctor.

Do not buy a second pack of Ranitidine Tablets without the advice of a doctor or pharmacist.

Do not give to children under 16 years of age.

If you take more Ranitidine Tablets than you should:

Immediate medical advice should be sought in the event of taking too many tablets or an overdose, even if you feel well.

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

STOP taking the tablets and seek urgent medical attention if your chest suddenly feels tight and you start to wheeze or get a skin rash, swelling of the face, lips, throat and eyelids or have unexplained fever or feel faint.

Tell your doctor straight away if any of the following side effects are noticed:

•    Changes in heart rate (faster or slower)

•    Acute pancreatitis (inflammation of the pancreas, which causes severe pain in the abdomen and back)

•    Vasculitis (inflammation of blood vessels) or a rash related to vasculitis

•    Inflammation of the kidney which can cause swollen ankles or high blood pressure

•    Hepatitis, with or without jaundice (yellowing of the skin or eyes) which are usually reversible

•    Highly or excessively sensitive reactions like an itchy skin eruption or skin peeling.

Other possible side effects:

Uncommon (may affect up to 1 in 100 people)

•    Diarrhoea, constipation

•    Nausea, abdominal pain.

Rare (may affect up to 1 in 1,000 people)

•    Abnormally low blood pressure

•    Rise in plasma creatinine levels

•    Changes in liver function.

Very rare (may affect up to 1 in 10,000 people)

•    Headache

•    Dizziness

•    Changes to blood counts (causing tiredness, bruising, fever or frequent infections)

•    Visual disturbances (including blurred vision)

•    Muscle and joint pains

•    Hair loss (alopecia)

•    Breast enlargement or milk from the breast

•    Erectile dysfunction (impotence) in men

•    Severe headache, confusion, hallucinations or depression (mainly in elderly or severely ill patients)

•    Involuntary movements.

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.

Keep out of the sight and reach of children.

Store in the original pack. Do not store above 25°C.

Do not take Ranitidine Tablets after the expiry date (EXP) printed on the pack. The expiry date refers to the last day of that month.

If you have any Ranitidine Tablets left, return them to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What is in Ranitidine Tablets?

Each tablet contains 75 mg Ranitidine as Ranitidine Hydrochloride.

The tablet also contains Microcrystalline Cellulose, Povidone, Magnesium Stearate, Hypromellose, Talc, Macrogol 6000, Methacrylic acid copolymer and the colouring agent E171.

Ranitidine Tablets are white to off-white, round biconvex film coated tablets with a break line on one side and the imprint “R75” on the other side.

Pack sizes: 5, 6, 10, 12. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

OTC Concepts Ltd, 2 Park Street, Woburn, Bedfordshire, MK17 9PG.

Manufacturer:

Rx Farma Ltd, Colonial Way, Watford, Herts, WD24 4YR, UK. This leaflet was last revised in July 2015