Minocycline Tablets Bp 100mg
PATIENT INFORMATION LEAFLET
? MINOCYCLINE
Tablets lOOmg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Minocycline Tablets are and what they are used for
2. Before you take Minocycline Tablets
3. How to take Minocycline Tablets
4. Possible side effects
5. How to store Minocycline Tablets
6. Further information
1. What Minocycline Tablets are and what they are used for
Minocycline belongs to a group of antibiotics called tetracyclines.
It may be used to treat a wide range of infections caused by bacteria which are sensitive to minocycline including:
• eye, ear, nose and throat infections
• respiratory tract infections such as pneumonia or bronchitis
• urinary tract or prostate infections
• soft tissue and skin infections, including the treatment of acne
• nocardiosis (an infection affecting the lungs or whole body)
• gonorrhoea (a sexually transmitted disease)
• pelvic inflammatory disease
• preventative treatment for meningitis carriers.
2. Before you take Minocycline Tablets
Do not take these tablets if you:
• are allergic to minocycline, tetracyclines or to any of the other ingredients in the tablets (see section 6)
• are pregnant, trying to become pregnant or breastfeeding
• have kidney failure
• have systemic lupus erythematosus (SLE). This is an allergic condition which causes joint pain, skin rashes and fever.
This medicine should not be given to children under 12 years of age, as it can cause permanent discoloration of growing teeth and damage tooth enamel.
Check with your doctor before taking these tablets if you:
• have liver or kidney problems
• have a condition called myasthenia gravis. This is a condition which causes muscle weakness, difficulty chewing or swallowing, and slurred speech.
Taking other medicines:
Check with your doctor before taking this medicine if you are taking, or have recently taken any other medicines, even those you have bought without a prescription. In particular, you should check with your doctor if you are taking:
• penicillin antibiotics e.g. amoxicillin
• oral contraceptives containing oestrogen. If you suffer from diarrhoea, sickness or bleed when you were not expecting a period whilst taking this medicine, your pill may not work properly and you should use an additional form of contraception
• heparin or other anti-coagulant drugs e.g. warfarin (used to prevent blood clotting)
• diuretics (also known as water tablets) e.g. furosemide
• retinoids such as isotretinoin or retinol (used to treat acne)
• ergot alkaloids e.g. ergotamine or methysergide (used to treat migraine)
• colestyramine and colestipol (used to lower cholesterol levels), as an interval of several hours is required between taking minocycline and these medicines
• quinapril (used to treat heart conditions) which contains magnesium carbonate
• medicines to treat ulcers which contain bismuth
• antacids (indigestion remedies), laxatives containing magnesium, any other medicines, vitamins or supplements containing iron, calcium, aluminium, magnesium, bismuth or zinc salts, as an interval of 3 hours is required between taking minocycline and these medicines
• medicines containing sodium bicarbonate, as an interval of 1 -2 hours is required between taking minocycline and these medicines
• other medicines which may produce skin reactions to sunlight
• medicines which can have a damaging effect on the liver
• the anaesthetic methoxyflurane.
Other special warnings:
Tests:
If you are taking this medicine for a long time your doctor will carry out blood, liver and kidney tests. This is quite usual and nothing to worry about.
This medicine may affect urine tests, so make sure the doctor knows you are taking minocycline tablets.
Alcohol:
If you do drink alcohol whilst taking this medicine the amount should remain within usual daily recommended limits. Speak to your doctor if you are unsure what this is.
Pregnancy and breast feeding:
Do not take if you are pregnant, trying to become pregnant or are breastfeeding.
Effects on driving and using machinery:
This medicine may cause light-headedness, dizziness, hearing problems such as ringing in the ears, headache or unsteadiness in some people. If you think you are affected do not drive or operate machinery.
Important information about one of the ingredients of this medicine:
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking this medicine.
3. Howto take Minocycline Tablets
Swallow the tablets whole with a glass of water.
Always take the medicine exactly as directed by your doctor. Your doctor will decide the dose that is best for you. The pharmacist's label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.
The usual doses for adults are:
General infections: 200 mg daily (to be taken in divided doses).
Acne: 50 mg twice a day for at least 6 weeks.
Gonorrhoea: 200 mg to start, followed by 100 mg every 12 hours for at least 4 days. Females may need longer treatment.
Preventative treatment in meningitis carriers: 100 mg
twice daily for 5 days. This is usually then followed by a course of another antibiotic, such as rifampicin.
Elderly: Your doctor will need to decide if any reduction in the usual doses above is required.
The usual dose for children over 12 years is: 50 mg
every 12 hours.
Not recommended for children under 12 years.
If you have been taking minocycline for six months and there is no improvement this medicine should be discontinued. If however it is continued your doctor will need to monitor you at least every three months for certain possible side effects.
If you have taken too many tablets:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
If you forget to take a dose:
Take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSE.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following occur STOP TAKING AND SEEK MEDICAL HELP IMMEDIATELY:
• a serious allergic reaction which may cause skin rash or itching, hives (raised red weals on the skin), inflammation, peeling or flaking of the skin, sometimes with swollen lymph nodes, fever or an increase in the number of white blood cells, along with inflammation of one or more of the following organs in the body: liver, lungs, kidneys, heart muscle or membrane around the heart
• other serious allergic reactions such as difficulty breathing, wheezing or dizziness, shock, a drop in blood pressure resulting in feeling faint or loss of consciousness, blood spots or bruising, sudden swelling of the face, neck, throat, lips, hands, feet or genitals
• Lupus-like syndrome or SLE (systemic lupus erythematosus) which causes joint pain, stiffness or swelling, along with one or more of the following: fever, muscle pain, rash, inflammation of the liver or blood vessels
• Serum sickness-like syndrome which may cause fever, hives, rash, joint pain, swelling or stiffness and an increase in the number of white blood cells
• blistering of the skin, eyes, mouth and genitals
• headache with blurred or double vision or loss of vision
• yellowing of the skin or whites of the eyes, feeling tired or weak, diarrhoea, loss of appetite, feeling or being sick, abdominal pain, pale stools and dark urine (may be due to inflammation of the liver or liver problems)
• breathlessness, cough and raised temperature (may be due to inflammation of the lungs)
• swollen ankles or high blood pressure (may be due to inflammation of the kidneys)
• chest pain, rapid or irregular heart beat, breathing difficulties and a dry cough (may be due to inflammation of the heart muscle or membrane)
• change in the colour of the skin, nails, teeth, inside the mouth, tongue, lips and gums, bones, thyroid, eyes, tears, sweat or breast milk
• increased skin sensitivity to sunlight. You should avoid direct exposure to sunlight or artificial light.
Tell your doctor straight away if you notice any of the following effects:
• worsening of asthma or the symptoms of SLE (systemic lupus erythematosus) if you already have this condition
• abdominal pain, cramps or swelling, severe pain in the abdomen and back
• an infection (due to bacteria resistant to this medicine) with symptoms such as a black hairy tongue, sore mouth, itching around the bottom or vagina, vaginal discharge or pain, abdominal pain, cramping or diarrhoea
• blood disorders which may cause symptoms such as tiredness, weakness, breathlessness, pale yellow skin, unexplained bruising or bleeding, sore throat, fever or make infections more likely
• kidney problems which may cause swollen ankles, shortness of breath, high blood pressure, more or less urine being produced, blood in the urine, fever, feeling or being sick, diarrhoea leading to dehydration, feeling drowsy or confused, weight loss or gain
The following other effects have been reported:
Common effects (may happen to less than 1 in 10 people):
• light-headedness.
Rare effects (may happen to less than 1 in 1,000 people):
• tender red lumps on the shins, hair loss
• headache, tingling or numbness in the hands and feet, weak sense of pain, heat, cold or touch, vertigo (feeling of dizziness or spinning)
• hearing problems, ringing in the ears
• cough, breathlessness, loss of appetite
• diarrhoea, feeling or being sick, sore mouth.
Very rare effects (may happen to less than 1 in 10,000 people):
• thrush, swelling around the tip of the penis
• bulging of the soft spot on the head of infants (this medicine should not be taken by children under 12 years anyway)
• indigestion, difficulty swallowing, tooth enamel defects, inflammation or ulceration of the oesophagus (gullet)
• muscle pain, arthritis, joint pain, stiffness or swelling
• abnormal function of the thyroid gland (detected in blood tests).
Other effects:
• fits, sleepiness
• fever.
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 Minocycline Tablets
Store below 25°C and protect from light and moisture.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information Ingredients:
Minocycline Tablets contain 100 mg of the active ingredient minocycline (as hydrochloride). The tablets also contain the following other ingredients: lactose, microcrystalline cellulose, pregelatinised starch, stearic acid, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol, titanium dioxide (E171) and iron oxides (E172).
What the medicine looks like:
Minocycline Tablets are buff coloured, film coated tablets and marked with the company logo on one side and A494 on the other side. This medicine is available in pack sizes of 28,
50, 100, 250, 500 and 1000 tablets (not all pack sizes may be marketed).
Who makes this medicine and holds the Product Licence:
Crescent Pharma Limited, Units 3 &4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK.
Date leaflet prepared: March 2016
If you would like this leaflet in a different format please contact the licence holder at the above address.