Ranitidine 150mg Tablets
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• 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 feeling unwell, itching, fever, yellowing of the skin and eyes or dark coloured urine
• unexplained hair loss
• diarrhoea
• impotence
• breast tenderness and/or breast enlargement
• breast discharge
• awareness of the heart beat and/or increased heart rate
Not known (frequency cannot be estimated from the available data)
• shortness of breath
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
Keep this medicine out of the sight and reach of children.
Store tablets in the original package and do not use after the expiry date stated on the label.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
If the tablets become discoloured or show signs of deterioration, you should seek the advice of your pharmacist.
6. Contents of the pack and other information What Ranitidine Tablets contain
Active substance is ranitidine hydrochloride equivalent to ranitidine 150mg or 300mg.
The other ingredients are microcrystalline cellulose, hypromellose, croscarmellose sodium, castor oil, colloidal anhydrous silica, purified talc, magnesium stearate, ferric oxide yellow (E172) and titanium dioxide (E171).
What Ranitidine Tablets look like and contents of the pack
Ranitidine Tablets are round, film-coated, creamish yellow tablets. The 150mg and 300mg tablets are embossed with "MR150" or "MR300".
The ranitidine tablets are available in blister sheets of 5, 7, 8, 10, 14, 15, 16, 20, 24, 28, 30, 32, 40, 45, 48, 50, 56, 60, 64, 72, 75, 80, 88, 90, 96, 98, 100, 105, 112, 120 and 150 tablets (not all pack sizes may be marketed).
This leaflet was last revised in July 2016
Ranitidine 150mg: PL No.: 21880/0091
Ranitidine 300mg: PL No.: 21880/0092
| POM |
Marketing Authorisation Holder and Manufacturer:
M MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK.
E-mail : info@medreich.co.uk
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Package leaflet: Information for the user
Ranitidine 150mg Tablets Ranitidine 300mg Tablets
(ranitidine 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 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 is and what it is used for
Ranitidine Tablets belong to a group of medicines called "H2-antagonists".
They reduce the amount of acid in your stomach and are used to treat:
• ulcers in the stomach or first part of the small intestine (duodenum)
• problems caused by acid in the food passage (reflux oesophagitis)
• Zollinger-Ellison syndrome and ulcers caused by serious illnesses
2. What you need to know before you take Ranidine Tablets Do not take RanitidineTablets if you:
• are allergic to ranitidine or any of the other ingredients of this medicine (listed in section 6)
If you are not sure, talk to your doctor or pharmacist before taking Ranitidine Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking RanitidineTablets:
• stomach cancer or a history of stomach cancer in your family
• kidney problems You will need to take a different amount of Ranitidine
• had stomach ulcers before and you are taking Non-Steroidal Anti- Inflammatory (NSAID) medicines
• a rare condition called acute porphyria (a rare inherited metabolism disorder which causes abdominal pains)
• you are over 65 years old
• lung disease
• you are diabetic
• any problems with your immune system
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
Other medicines and Ranitidine Tablets
Please tell your doctor or pharmasist if you are taking ,have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Ranitidine can affect the way some other medicines work. Also some other medicines can affect the way Ranitidine works.
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In particular, tell your doctor of pharmacist if you are taking any of the following medicines.
• Non-Steroidal Anti-Inflammatory (NSAID) medicines, for pain and inflammation
• Lidocaine, a local anesthetic
• Propanolol, procainamide or n-acetylprocainamide, for heart problems
• diazepam, for worry or anxiety problems
• Phenytoin (treatment of epilepsy)
• Theophylline, for breathing problems (asthma)
• Warfarin for thining your Blood
• Glipizide, for lowering blood glucose
• Atazanavir or Delaviridine for treating HIV infection
• Gefitnib, for lung cancer
• Triazolam, for insomnia
• ketoconazole (an antifungal agent)
• sucralfate, for treating stomach ulcers
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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ranitidine.
Pregnancy and Breast Feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. You should not take this medicine unless your doctor advises it is essential.
Ranitidine Tablets contains Caster Oil which may cause stomach upsets and diarrhoea.
3. How to take Ranitidine Tablets
Ranitidine Tablets should be swallowed whole with a glass of water. Always take Ranitidine Tablets exactly as your doctor has told you. The usual doses are as follows:
Adults
Treatment of stomach or duodenal ulcers:
Take one 150mg tablet twice a day, one in the morning and one in the evening OR one 300mg tablet at bedtime.
For maintenance, the usual dose is 150mg at bedtime. Recommended duration of treatment is 4 to 8 weeks
Treatment of reflux oesophagitis:
Take one 150mg tablet twice a day OR one 300mg tablet at bedtime. In severe oesophagitis, take one 150mg tablet four times a day for a maximum of 12 weeks.
Zollinger-Ellison syndrome:
Take one 150mg tablet three times a day. This may be increased as necessary
Patients with Kidney disease:
Your doctor may prescribe a lower dosage and will tell you how long to take the tablets for. The dose is usually 150mg at night for 4-8 weeks but will depend on the type and severity of your disease. If healing has not occurred, take 150 mg twice daily, followed by 150mg at night for maintenance.
Elderly
In patients with normal renal function, the doses of Ranitidine Tablets are the same as for younger adults.
Children
The recommended oral dose for the treatment of peptic ulcer is 4 mg/kg/day to 8mg/kg/day administered as two divided doses, to a maximum dose of 300 mg ranitidine per day.
If you take more Ranitidine Tablets than you should
If you or someone else swallows more tablets than they should, contact a doctor or the nearest hospital emergency department immediately, taking any remaining tablets and the box if possible.
If you forget to take Ranitidine Tablets
If you miss a dose, take your dose as soon as you can, then carry on as before. Do not take an extra dose to make up for the forgotten one.
If you stop taking Ranitidine Tablets
Take Ranitidine Tablets as directed for as long as your doctor has told you. Do not stop taking them, even if you feel better, because your symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all other medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment:
• allergic reactions, the signs may include:
- 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 something called 'pancreatitis'
• a slow or irregular heartbeat, flushing or marks on your skin that look like targets (Erythema multiforme)
The following side effects have been reported:
Uncommon (may affect up to 1 in 100 people)
• stomach pain
• constipation
• feeling sick (nausea)
Rare (may affect up to 1 in 1,000 people)
• skin rash
Rare side effects that may show up in blood tests:
• increase of serum creatinine in the blood (kidney function test)
• changes to liver function
Check with your doctor as soon as possible if you notice any of the following:
Very rare (may affect up to 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)
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