PACKAGE LEAFLET: INFORMATION FOR THE USER

_ _ _ _ _ _n nogen PharmaI

¹ Ranitidine Tablets 150mg and 300mg

I [Ranitidine hydrochloride]

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

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

I If you have any further questions, ask your | doctor, or pharmacist or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2.    What you need to know before you take | Ranitidine Tablets

3.    How to take Ranitidine Tablets

4.    Possible side effects

5.    How to store Ranitidine Tablets

6.    Contents of the pack and other information

1. WHAT RANITIDINE TABLETS ARE AND WHAT THEY ARE USED FOR

Ranitidine Tablets belong to a group of medicines called H2-receptor antagonists which act to decrease the natural production of acid in the stomach.

Ranitidine Tablets have been prescribed to treat any of the following:

•    Ulcers in the upper part of the intestine (duodenal ulcer) including those associated

I with infections caused by Helicobacter pylori.

•    Benign stomach ulcer

•    Acid from the stomach escaping into the food pipe causing pain, inflammation and heartburn (oesophageal reflux disease)

•    Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome)

•    Ulcers in the stomach or duodenum which may be caused by non-steroidal anti-inflammatory

I medicines (NSAIDs) which are used to treat pain, fever and inflammation

•    Various conditions where reduction of stomach acid and secretions is considered beneficial

I e.g. for indigestion symptoms (e.g. stomach pain or discomfort, heartburn), which are related to meals and disturbed sleep

•    To prevent stress ulcers in seriously ill patients

•    To prevent stomach ulcers from bleeding

•    Before general anaesthesia, to prevent damage to the lungs in patients at risk of

' breathing in stomach fluid during surgery.

Children (3-18 years):

•    Peptic ulcers

•    Oesophageal reflux disease (see above)

I For dosage see Section 3 How to take

Ranitidine Tablets.

possible causes of your symptoms (such as stomach cancer) should be investigated before taking or continuing to take Ranitidine Tablets

•    Suffer from or have a history of porphyria

•    Have lung disease

•    Are diabetic

•    Have any problems with your immune system.

Other medicines and Ranitidine Tablets:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription and herbal medicines. This is because Ranitidine Tablets can affect the way some other medicines can work. Also some other medicines can affect the way Ranitidine Tablets work.

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

•    Gefitinib, for lung cancer

•    Ketoconazole, an anti-fungal medicine, sometimes used for treating thrush.

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice if you are pregnant, planning on becoming pregnant or are breast-feeding. You should not take this medicine unless your doctor advises it is essential.

Driving and using machines

These tablets can cause some people to feel dizzy or drowsy. If you are affected do not drive or operate machinery.

3. HOW TO TAKE RANITIDINE TABLETS

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RANITIDINE TABLETS

Do not take Ranitidine Tablets:

•    If you are hypersensitive (allergic) to ranitidine I or any of the other ingredients of Ranitidine

Tablets.

Warnings and precautions

Talk to your doctor, or pharmacist or nurse before taking Ranitidine Tablets if you:

•    Suffer or have suffered in the past from severe kidney disease

•    Have a history of peptic ulcer, particularly if you are elderly and are taking a non-steroidal antiinflammatory drug (NSAID) e.g. aspirin,

I ibuprofen, naproxen, diclofenac

•    Are middle aged or over, with new or recently I changed indigestion symptoms e.g stomach

pain or discomfort, heartburn - because other

Always take Ranitidine Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The usual dosage is 150mg twice daily. As an alternative, 300mg can be taken as a single dose at bedtime.

Elderly:

The normal adult dosage may be used unless the patient has kidney problems.

Patients with duodenal ulcers associated with NSAID treatment: 150mg twice daily during NSAID treatment.

Patients with duodenal ulcers associated with Helicobacter pylori:

The usual dose of ranitidine 150mg should be given together with amoxicillin 750mg three times daily and metronidazole 500mg three times daily for a period of two weeks. Ranitidine should then be continued for two weeks.

Patients with oesophageal reflux disease:

150mg twice daily or 300mg at bedtime for 8 to 12 weeks. The dose may be increased by your doctor. Ranitidine is not recommended for long term treatment of patients with unhealed oesophagitis.

Patients with Zollinger-Ellison syndrome:

Initially 150mg three times daily. The dose may be increased up to 6000mg daily.

Prevention of Mendelson's syndrome:

|150mg two hours before induction of anaesthesia can be given to patients at risk from acid aspiration. An additional dose of 150mg given the night before anaesthesia is desirable.

In obstetric patients during labour, 150mg dose should be given at 6 hourly intervals. Patients needing emergency anaesthesia should be given a non-particulate antacid, while maintaining standard precautions for the prevention of inhalation of gastric contents.

To prevent stress ulceration (in seriously ill patients) and to prevent ulcers from bleeding:

When oral administration is appropriate 150mg twice daily may be given.

Patients with kidney problems:

150mg at bedtime for 4 to 8 weeks, as a maintenance dose, if necessary.

If the ulcer has not healed after treatment, 150mg twice daily should be taken. If necessary, followed by a maintenance treatment of 150mg at night.

Children 12 years and over:

For children 12 years and over after the adult ^osage is given.

Children 3- 11 years or weighing more than 30kg:

Your doctor will work out the correct dose for your child.

Peptic ulcers: 2mg/kg to 4mg/kg twice daily to a maximum of 300mg daily.

Oesophageal reflux disease: 5mg/kg to 110mg/kg/day administered in two divided doses up to a maximum of 600mg (this is likely to apply to heavier children or adolescents with severe symptoms).

|lf you take more Ranitidine Tablets than you should

This medicine is to be taken at regular intervals, as determined by the doctor. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

If you stop taking Ranitidine Tablets

You may feel better after a few days, but you should keep taking your tablets until the prescribed course is finished. Your symptoms may come back |if you stop your treatment too soon.

If you forget to take Ranitidine Tablets

If you have forgotten to take a dose, leave out that dose completely. Take your next dose at the jnormal time. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

Rare (affects up to 1 in 1,000 people) • Skin rash.

Check with your doctor as soon as possible if you notice any of the following:

Very rare (affects less than 1 in 10,000

people)

•    There can be changes in the level of | certain substances in your blood. This

can lead to you feeling unusually tired or short of breath and being more likely to bruise or get an infection

•    Feeling depressed, confused, seeing or hearing unexplained things (hallucinations)

•    Headache (sometimes severe)

•    Feeling dizzy or having blurred vision

•    Your joints or muscles are painful or swollen or you cannot control their movement

•    Your small blood vessels can become swollen (known as vasculitis). Signs of this can include a rash, swollen joints or kidney problems

•    Your liver can become swollen. This can lead to nausea (feeling sick) or vomiting (being sick), loss of appetite or generally felling unwell, itching, fever, yellowing of the skin and eyes or dark coloured urine

•    Flushing or marks on your skin that look like targets

•    Unexplained hair loss

•    Impotence

•    Breast tenderness and/or breast enlargement

•    Breast discharge

•    Increase of serum creatinine in the blood (kidney function test)

•    Changes to liver function

•    Diarrhoea.

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 RANITIDINE TABLETS

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

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

In case of any visible signs of deterioration, you should discard the package.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment. Keep out of the sight and reach of children.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ranitidine Tablets can cause side effects. Although not everybody gets them.

Stop taking Ranitidine Tablets and see a doctor immediately, if you notice any of the following serious side effects, you may need urgent medical treatment:

•    Rash, itching or hives on the skin

•    Swelling of your face, lips, tongue or other | parts of the body

•    Chest pain, shortness of breath, wheezing or having trouble breathing

•    Unexplained fever and feeling faint, especially when standing up

•    Kidney problems, which can lead to back pain, fever, pain when passing urine, blood in the urine and changes in blood tests

•    Severe stomach pain, this may be a sign of a condition called 'pancreatitis'

p A slow or irregular heart beat.

Check with your doctor at your next visit if you

notice any of the following:

Uncommon (affects less than 1 in 100 people)

•    Stomach pain

•    Constipation

•    Feeling sick (nausea).

What Ranitidine Tablets contain:

Ranitidine Tablets 150mg and 300mg contain the active substance ranitidine hydrochloride 150mg and 300mg respectively.

The other ingredients are:- Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, talc, macrogol 6000, polymethacrylate.

What Ranitidine Tablets look like and contents of the pack:

Ranitidine 150mg Tablets: Circular biconvex, white to yellowish film coated tablets with R1 debossed on one side.

Ranitidine 300mg Tablets: Oblong, white to yellowish film coated tablets with R2 debossed on one side.

Ranitidine 150mg and 300mg Tablets are packed in blister strips in pack sizes of: 7, 14, 15, 20, 21, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168 and 240. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last amended in June 2015