150 mg tablets
ranitidine
What Ranitidine Mylan is and what it is used for
Ranitidine Mylan belongs to a group of medicines called H 2 -receptor blockers and works by reducing the amount of acid in your stomach.
Ranitidine Mylan is used in adults (18 years and older) to:
- heal wounds in the stomach or the part of the intestine that the stomach opens into ( duodenum one)
- prevent stomach ulcers
- prevent gastric ulcers from bleeding
- cure or prevent problems caused by acid in the esophagus (esophagus) or too much acid in the stomach. Both of these problems can cause pain or discomfort, sometimes referred to as “indigestion”, “dyspepsia” or “heartburn”.
- Avoid acid from entering the esophagus from the stomach during anesthesia during surgery.
For children (3 to 18 years) Ranitidine Mylan is used to:
- heal wounds in the stomach or the part of the intestine into which the stomach results ( duodenum ).
- cure or prevent problems caused by acid in the esophagus (esophagus) or too much acid in the stomach. Both of these problems can cause pain or discomfort, sometimes referred to as “indigestion”, “dyspepsia” or “heartburn”.
Ranitidine contained in Ranitidine Mylan may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions
What you need to know before using Ranitidine Mylan
Do not use Ranitidine Mylan
- if you are allergic to ranitidine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Ranitidine Mylan if you:
- have cancer of the stomach
- have impaired renal or hepatic function
- has had acute porphyria (an unusual condition with increased turnover of porphyrins)
- is older than 65 years
- have any lung disease
- have diabetes
- have a problem with your immune system
- have had stomach ulcers before and you are using non-steroidal anti-inflammatory drugs ( NSAIDs )
Other medicines and Ranitidine Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ranitidine Mylan tablets may affect or be affected by certain medicines that contain the following active substance (s):
- Procainamide or n-acetyl procainamide for heart problems
- Warfarin or coumarin, to thin the blood
- Glipizide, to reduce blood sugar
- Atazanavir or delavirdine, for the treatment of HIV
- Triazolam, for insomnia
- Gefitinib, for the treatment of lung cancer
- Erlotinib, for the treatment of certain types of cancer. Ranitidine contained in Ranitidine Mylan may reduce the amount of erlotinib in your blood and your doctor may need to adjust your treatment when used concomitantly.
- Ketoconazole, against fungal infections, is sometimes used to treat cod
- Midazolam is a medicine you can get just before an operation. Tell your doctor that you are taking ranitidine before surgery.
- Theophylline (bronchodilator)
- Phenytoin (used in epilepsy )
- Non-steroidal anti-inflammatory drugs ( NSAIDs ), for pain and inflammation
Antacids and sucralfate may impair the uptake of ranitidine and therefore ranitidine should be taken approximately 2 hours before taking these drugs. The effect of alcohol may be enhanced by concomitant use of Ranitidine Mylan.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take Ranitidine Mylan without consulting your doctor. Your doctor will assess the risks and benefits to you and your child when using Ranitidine Mylan.
Ranitidine is excreted in breast milk, which leads to an increased risk of effects on the baby. Breast-feeding should be avoided during treatment with Ranitidine Mylan.
Driving and using machines
Side effects such as headache, dizziness, and fatigue are common. Under such circumstances, the ability to react and the judge may be reduced, so that the ability to drive vehicles and use machines is impaired.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Ranitidine Mylan
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Recommended dose:
Adults and adolescents from 12 years:
The dose is determined by your doctor, who will tailor it for you. The usual dose is 150 mg in the morning and evening or 300 mg at night. In more severe cases, the dose may be increased. In preventive treatment, 150 mg is usually given overnight. Always follow your doctor’s prescription.
Children from 12 years and up :
Children from 12 years and up are given the same dose as adults.
Children from 3 to 11 years and over 30 kg in body weight:
Acute treatment of stomach ulcers: the doctor determines the dose based on the child’s body weight, but never more than 300 mg per day. The treatment normally lasts 4 weeks, but if the healing of the stomach ulcer is not complete, an additional 4 weeks of treatment may be needed.
Treatment of symptoms of acid reflux of gastric acid up into the esophagus ( gastroesophageal reflux disease ): the doctor determines the dose based on the child’s body weight, but never more than 600 mg per day.
If you take more Ranitidine Mylan than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital by mistake for assessment of the risk and advice.
Possible side effects
Like all medicines, Ranitidine Mylan can cause side effects, although not everybody gets them.
Symptoms you should be aware of:
Allergic reactions: These are rare in people taking Ranitidine Mylan. Symptoms include:
- raised and itchy rash ( hives )
- swelling, sometimes of the face and mouth ( angioedema )
- chest pain, shortness of breath, unexplained fever, wheezing, or difficulty breathing
- fainting sensation, especially when standing up
- collapse.
→ Contact a doctor immediately if you get any of these symptoms. Stop taking Ranitidine Mylan.
Severe skin reactions: These are very rare in people taking Ranitidine Mylan. Symptoms include:
- Skin rash (erythema multiforme), which can form blisters and look like small targets (central dark dots surrounded by a lighter area, with a dark ring around the edge).
→ Contact a doctor immediately if you get any of these symptoms. Stop taking Ranitidine Mylan.
Uncommon side effects are
These can affect up to 1 in 100 users:
- abdominal pain, constipation, nausea
Rare side effects
These can affect up to 1 in 1000 users:
- allergic reactions, such as hives, angioedema , fever, respiratory cramps, low blood pressure, and chest pain
- skin reactions
- impaired renal function (usually mild, normalizes with continued treatment)
- transient changes in liver function tests
- liver failure, sometimes fatal
Very rare side effects
These can affect up to 1 in 10,000 users:
- allergic shock
- inflammation of the blood vessels ( vasculitis )
- inflammation of the pancreas ( pancreatitis )
- inflammation of the liver ( hepatitis ), sometimes with yellowing of the whites of the eyes or skin (jaundice)
- inflammation of the kidneys (interstitial nephritis)
- slow or irregular heartbeat ( bradycardia ), disturbance of the cardiac conduction system (atrioventricular block), increased heart rate ( tachycardia )
- diarrhea
- the feeling of confusion, depression, or seeing and hearing things that do not exist (hallucinations)
- joint or muscle pain
- headache, dizziness, blurred vision
- unusual hair loss or thinning ( alopecia )
- inability to get or maintain an erection ( impotence )
- unusual secretion of breast milk or breast augmentation in men
- low white blood cell count
- decreased number of platelets (cells that help the blood clot)
- decreased number of all kinds of blood cells
- severe skin reaction (erythema multiforme)
- involuntary movements such as tremors and muscle twitching.
No known frequency
This can not be calculated from the available data
- Respiratory distress
How to store Ranitidine Mylan
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 carton after EXP. The expiration date is the last day of the specified month.
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.
Contents of the pack and other information
Content declaration
- The active substance is ranitidine hydrochloride equivalent to ranitidine 150 mg.
- The other ingredients are microcrystalline cellulose, magnesium stearate, hypromellose, titanium dioxide (dye E 171), polydextrose, triethyl citrate, and macrogol.
What the medicine looks like and the contents of the pack
White to beige, cupped, film-coated, marked “00/30” and “G”.
Pack sizes:
Plastic jar 20, 60, and 90 tablets.
Plastic jar 250 tablets only for dose dispensing / hospital use.
Pressure pack 60, 90 and 50×1 (single dose) tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Mylan AB
Box 23033
104 35 Stockholm