Ranitidine 75mg Tablets
Package leaflet: Information for the user
Ranitidine 75 mg film-coated tablets
Active substance: Ranitidine (as hydrochloride)
For use in adults and adolescents from 16 years of age
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
- 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 14 days.
What is in this leaflet
1. What Ranitidine 75 mg is and what it is used for
2. What you need to know before you take Ranitidine 75 mg
3. How to take Ranitidine 75 mg
4. Possible side effects
5. How to store Ranitidine 75 mg
6. Contents of the pack and other information
1. What Ranitidine 75 mg is and what it is used for
Ranitidine 75 mg belongs to a group of medicines known as H2-receptor antagonists which reduce the amount of acid in your stomach.
Ranitidine 75 mg is used
for the short-term, symptomatic treatment of heartburn.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days
2. What you need to know before you take Ranitidine 75 mg Do not take Ranitidine 75 mg:
- if you are allergic to Ranitidine or any of the other ingredients of this medicine (listed in section 6). Ranitidine 75 mg may not be given to children under 16 years of age.
Warning and precautions
Talk to your doctor or pharmacist before taking Ranitidine 75 mg:
- if you have ever suffered from a stomach or intestinal ulcer.
- if you are inadvertently losing weight in association with existing indigestion problems.
- if you suffer from kidney or liver problems, or any other illness which requires regular medical supervision.
- if you suffer from any other illness, or are taking other medicines, that your doctor has prescribed or that you have bought yourself.
- if you are taking painkillers such like non steroidal anti-inflammatory drugs (e.g. ibuprofen, acetyl salicylic acid), especially if you are elderly, you should seek your doctor’s advice before taking
Ranitidine 75 mg .
- if you have a history of porphyria (a severe illness whose symptoms include severe stomach pain, mental confusion and muscle weakness), as your doctor may decide that this medicine is not suitable for you.
- if you are elderly, if you have a chronic lung disease, diabetes or problems with your immune system, you may have an increased risk of developing community acquired pneumonia.
Treatment with Ranitidine 75 mg can mask the symptoms of more serious diseases, such as stomach cancer, and thus delay diagnosis of this disease. Therefore, it is important that your doctor has established that you do not have a malignant ulcer before starting treatment. This particularly applies to middle aged or older patients who have symptoms of indigestion that have recently appeared or changed.
Other medicines and Ranitidine 75 mg
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
This particularly applies to the following medicines:
- coumarin anticoagulants (e. g. warfarin, for thinning your blood)
- procainamide and N-acetylprocainamide (medicines for the treatment of cardiac arrhythmias)
- triazolam, midazolam (mood-enhancing drugs)
- glipizide (medicine for the treatment of diabetes)
- ketoconazole (medicine for the treatment of fungal infections)
- atazanavir, delaviridine (medicine for treatment of HIV infection)
- gefitinib (medicine for treatment of lung cancer)
You should always take medicines which reduce stomach acid (e.g. antacids, sucralfate) 2 hours after Ranitidine 75 mg, in order to prevent a reduction in the efficacy of Ranitidine 75 mg.
Ranitidine 75 mg with food, drink and alcohol
This medicine can be used with or without a meal.
Intake of Ranitidine 75 mg can enhance the effect of alcohol.
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 or pharmacist for advice before taking this medicine.
During pregnancy you should not take Ranitidine 75 mg without asking your doctor.
Ranitidine passes into breast milk. You should avoid breast-feeding while taking Ranitidine 75 mg as this may cause stomach acid secretion disorders in your child.
Driving and using machines
No effects on the ability to drive or operate machinery were reported.
3. How to take Ranitidine 75 mg
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
|
Single dose |
Total daily dose | |
|
Adolescents over 16 years and above |
1 film-coated tablet (equivalent to 75 mg Ranitidine) if complaints occur, during the day or night |
A maximum dose of 2 film-coated tablets (equivalent to 150 mg Ranitidine) in 24 hours |
|
Children under 16 years of age |
Use in children under 16 years of age is not recommended. | |
Do not take Ranitidine 75 mg for longer than 14 days without your doctor’s advice.
You must contact a doctor if your symptoms worsen or do not improve after 14 days.
Method of administration
Film-coated tablets for oral administration.
Please take the film-coated tablets with sufficient liquid (e.g. a glass of water).
If you have the impression that the effect of Ranitidine 75 mg is too strong or too weak, please talk to your doctor or pharmacist.
If you take more Ranitidine 75 mg than you should
If intentional or accidental overdose occurs, you should immediately consult your doctor, who will undertake supportive treatment appropriate to the complaints.
If you forget to take Ranitidine 75 mg
Do not take a double dose to make up for a forgotten tablet/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 everybody gets them.
Serious side effects
A few people can be allergic to some medicines. These reactions can occur following administration of a single dose. If any of the following side effects come on soon after taking these tablets, stop the tablets and tell your doctor immediately or go to the casually department at your nearest hospital:
- hives, swelling of tongue, lips, face and throat (angioedema), fever, constriction of the airways, drop in blood pressure, inadequate blood flow through the body (circulatory shock), chest pain. These side effects occur rarely (may affect up to 1 in 1,000 people).
Other possible side effects
Common (may affect up to 1 in 10 people)
- tiredness
Uncommon (may affect up to 1 in 100 people)
- abdominal pain, constipation, feeling sick (these symptoms mostly improved during continued treatment)
Rare (may affect up to 1 in 1,000 people)
- a slight rise in one laboratory value (serum creatinine) (usually slight; normalised during continued treatment)
- hypersensitivity reactions e. g. urticaria (reddening of the skin with itching), angioneurotic oedema (serious allergic reaction which causes swelling of the face or throat), fever, bronchospasm (difficulty in breathing or wheezing), low blood pressure and chest pain
- transient and reversible changes in liver function tests
- skin rash, itching
Very rare (may affect up to 1 in 10,000 people)
- there can be changes in the level of certain substances in your blood (leucopenia, thrombocytopenia, agranulocytosis, pancytopenia). This can lead to you feeling unusually tired or short of breath and being more likely to bruise or get an infection.
- anaphylactic shock (serious allergic reaction which causes difficulty in breathing or dizziness).
This event has been reported after a single dose.
- reversible mental confusion, depression and hallucinations. These have been reported predominantly in severely ill patients, elderly patients and patients with kidney disease.
- headache (sometimes severe), dizziness and reversible involuntary movement disorders
- reversible blurred vision. There have been reports of blurred vision, which is suggestive of a change in accommodation.
- as with other H2 receptor antagonists tachycardia (increased heart rate), bradycardia (slower heart beat) and AV block (disturbances in the conduction [flow] of electrical impulses passing from the upper to the lower chambers of the heart)
- vasculitis (your small blood vessels can become swollen, often with skin rash)
- acute pancreatitis (inflammation of the pancreas, which causes severe pain in the abdomen and back)
- diarrhoea
- an inflammation of the liver due to a virus or other insult to the liver (hepatitis) with or without jaundice, these were usually reversible
- a particular form of skin rash (Erythema multiforme)
- hair loss
- your joints or muscles are painful or swollen or you cannot control their movement (arthralgia and myalgia)
- inflammation of the kidneys (acute interstitial nephritis)
- reversible impotence, breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea)
Not known (frequency cannot be estimated from the available data)
- dyspnoea (difficulties to breathe)
Reporting of side effects
If you get 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 75 mg
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister pack and carton. The expiry date refers to the last day of that month.
Do not store above 25 °C.
6. Contents of the pack and other information
What Ranitidine 75 mg contains
The active substance is Ranitidine.
Each film-coated tablet contains 83.75 mg Ranitidine hydrochloride, equivalent to 75 mg Ranitidine.
The other ingredients are:
microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, talc, castor oil, hypromellose, titanium dioxide (E 171), iron oxide red (E 172).
What Ranitidine 75 mg looks like and contents of the pack
Ranitidine 75 mg are pink, round film-coated tablets.
Ranitidine 75 mg is available in packs containing 6, 10, 12, 20, 24 and 28 film-coated tablets. Marketing authorisation holder
Ratiopharm GmbH, Ludwig-Merckle-Str. 3, D-89079 Blaubeuren, Germany.
Manufacturer
Merckle GmbH, Ludwig-Merckle-Str. 3, D-89143 Blaubeuren, Germany.