MACRODANTIN 50 MG CAPSULES HARD - patient leaflet, side effects, dosage

Macrodantin® 50mg Capsules, Hard

(nitrofurantoin)

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

The name of your medicine is Macrodantin 50mg Capsules, Hard. It will be referred to as Macrodantin Capsules for ease hereafter. Other strength 100mg is also available.

What is in this leaflet:

• 1. What Macrodantin Capsules are and what they are used for

• 2. What you need to know before you take Macrodantin Capsules

• 3. How to take Macrodantin Capsules

• 4. Possible side effects

• 5. How to store Macrodantin Capsules

• 6. Contents of the pack and other information

1. What Macrodantin Capsules are and what they are used for

Nitrofurantoin (the active substance in Macrodantin Capsules) is an antibiotic.

It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract.

You must talk to a doctor if you do not feel better or if you feel worse.

2. what you need to know before you take macrodantin capsules

DO NOT TAKE Macrodantin Capsules:

• ■ if you are allergic to nitrofurantoin, other medicines containing nitrofurantoin or to any of the other ingredients of this medicine (listed in section 6)

• ■ if you have a disease of the kidneys which is severely affecting the way they work (ask your doctor if you are not sure)

• ■ if you are in the final stages of pregnancy (labour or delivery) as there is a risk that it might affect the baby

• ■ if you suffer from a blood disorder called porphyria

• ■ if you are deficient in an enzyme called G6PD (glucose-6-phosphate dehydrogenase)

• ■ if your child is under three months of age

• ■ if you are breast feeding a baby with suspected or known deficiency in an enzyme called G6PD (glucose-6-phosphate dehydrogenase).

Tell your doctor if you are not sure about any of the above.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Macrodantin Capsules:

• ■ if you have diabetes

• ■ if you are suffering from any illness causing severe weakness

• ■ if you have anaemia (a decrease in red blood cells causing pale skin, weakness and breathlessness); or a lack of vitamin B or abnormal levels of salts in your blood (your doctor will be able to advise you)

• ■ if you have a history of allergic reactions.

• ■ if you have any problems with your kidneys

The above conditions may increase the chance of developing a side effect which results in damage to the nerves, causes altered sense of feeling, pins and needles.

• ■ if you lack an enzyme (body chemical) called glucose-6-phosphate dehydrogenase, which causes your red blood cells to be more easily damaged (this is more common in black people and people of Mediterranean, Middle Eastern or Asian origin. Your doctor will know)

• ■ if you have any disease of the lungs, liver or nervous system. If you need to take Macrodantin Capsules for a number of months, your doctor may want to regularly check how your lungs and liver are working.

• ■ as this medicine may interfere with urine tests for glucose, causing the test to give a “false positive” result. That is, the test may say that glucose is present in the urine even if it is not.

• ■ This medicine may also cause your urine to turn yellow or brown.

• ■ If you experience fatigue, yellowing of the skin or eyes, itching, skin rashes, joint pain, abdominal discomfort, nausea, vomiting, loss of appetite, dark urine, and pale or grey-coloured stools. It may be symptoms of liver disorder.

Other medicines and Macrodantin Capsules

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If they are taken with Macrodantin Capsules their effect or the effect of Macrodantin Capsules may be changed.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• ■ Antacids for indigestion (e.g. magnesium trisilicate)

• ■ Medicines for gout (e.g. probenecid or sulfinpyrazone)

• ■ Medicines which slow the passage of food through the stomach (e.g. atropine, hyoscine)

• ■ Medicines for raised pressure in the eye (glaucoma), such as carbonic anhydrase inhibitors (e.g. acetazolamide)

• ■ Medicines which make the urine less acidic (e.g. potassium citrate mixture)

• ■ Medicines for infections, known as quinolones

• ■ Typhoid vaccine, which is given for the prevention of typhoid.

If you are in doubt about any of these medicines, ask your doctor or pharmacist.

Macrodantin Capsules may interfere with the results of some tests for glucose in the urine.

Macrodantin Capsules with food and drink: Macrodantin Capsules should always be taken with food or milk. Taking this medicine with food or milk makes it work more effectively. This will help to avoid stomach upset and also to help the absorption.

Pregnancy, breast-feeding and fertility:

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. As far as it is known Macrodantin Capsules may be used in pregnancy. However, it should not be used during labour or delivery because there is a possibility that use at this stage may affect the baby.

If you want to breast feed, please consult your doctor first.

Driving and using machines:

Macrodantin Capsules may cause dizziness and drowsiness. You should not drive or operate machinery if you are affected this way until such symptoms go away.

Macrodantin Capsules contain lactose and sodium This medicine contains lactose. If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23mg) per dosage, that is to say essentially ‘sodium-free’.

3. how to take macrodantin capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults:

The normal dosage depends on the type of infection you have and instructions should be written on the label provided by the pharmacist. Consult your pharmacist or doctor if these instructions are not clear. The usual doses are:

• ■ For treatment of infections:

One 50mg capsule four times a day for seven days

• ■ For prevention of further infections:

One 50mg capsule at bedtime

• ■ For prevention of infections during surgery:

One 50mg capsule four times a day on the day of the operation and three days thereafter.

Use in children and infants over three months of age:

The dose depends on the weight of the child and will be provided by your doctor. Follow your doctor’s instruc­tions exactly.

Children below 3 months of age should not take Macrodantin Capsules.

Medical Checks:

Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system.

Macrodantin Capsules may interfere with the results of some tests for glucose in the urine.

Method of administration

Macrodantin Capsules should always be taken with food or milk. Taking this medicine with food or milk makes it work more effectively.

If you take more Macrodantin Capsules than you should:

Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any leftover capsules with you, as well as the container and label, so that the medical staff knows what you have taken.

If you forget to take Macrodantin Capsules:

Do not worry. If you remember later on that day, take that day’s dose as usual. If you miss a whole day’s dose take the normal dose on the next day. Do not take a double dose to make up for a forgotten capsule. If you are not sure ask your doctor or pharmacist.

If you stop taking Macrodantin Capsules:

Your doctor will tell you how long to take the treatment.

Do not stop earlier than you are told, even if you feel better. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of them are mild and disappear when you stop taking Macrodantin Capsules.

All medicines can cause allergic reactions although serious allergic reactions are rare. If you notice any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) STOP TAKING your medicine and go to a doctor immediately.

If you experience any of the side effects detailed below stop taking Macrodantin Capsules and consult your doctor.

• ■ Your lungs may react to Macrodantin Capsules. This may develop quickly, within a week of starting treatment or very slowly, especially in elderly patients. This may produce fever, chills, cough and shortness of breath

• ■ Jaundice (inflammation of the liver causing yellowing of the skin or whites of the eyes)

• ■ The nerves outside the spinal cord may be affected causing changes to the sense of feeling and the use of muscles. In addition, headache, extreme changes of mood or mental state, confusion, weakness, blurred vision may occur. These effects may be severe and, in some instances, permanent

• ■ Raised pressure in the skull (causing severe headaches).

• ■ Severe reduction in blood cells which can cause weakness, bruising or make infections more likely

• ■ Blue or purple colouration of the skin due to low oxygen levels. A condition known as cyanosis.

• ■ Symptoms of fever, flu, abdominal pain, diarrhoea, blood in your stool and weakness. These could be signs of a condition known as cutaneous vasculitis.

• ■ Symptoms of jaundice, fatigue, abdominal pain, joint pain and swelling. These could be signs of a condition known as autoimmune hepatitis.

Please note that while taking Macrodantin Capsules your urine may become dark yellow or brown coloured. This is quite normal and not a reason to stop taking the medicine.

Other side effects include:

Rare (may affect up to 1 in 1,000 people)

■ Loss of consciousness (collapse).

Not known (frequency cannot be estimated from the available data)

• ■ Feeling sick (nausea) and headache

• ■ Loose stools

• ■ Loss of appetite, stomachache, and being sick

(vomiting)

• ■ Dizziness, drowsiness

• ■ Blood cells have been affected in some patients. This may result in bruising, delayed clotting of the blood, sore throat, fever, anaemia, and a susceptibility to colds or persistent cold

• ■ A variety of skin rashes or reactions have occurred in some patients. These may appear as flaking skin, a red rash or fever accompanied by rapid heart rate and severe rash with blistering. Other reactions may include inflammation of salivary glands (causing facial pains), inflammation of the pancreas (causing severe abdominal pain) and joint pains

• ■ Short-term hair loss

• ■ Urinary infection by germs which are not sensitive to Macrodantin Capsules

• ■ Inflammation of small blood vessel walls, causing skin lesions

• ■ Liver inflammation due to turn of immune system against liver cells

• ■ Inflammation of kidney tissue surrounding tubules, causing renal impairment.

5. how to store macrodantin capsules

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original package in order to protect from light and moisture.

Do not use Macrodantin Capsules after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.

If your doctor decides to stop treatment, return any leftover capsules to the pharmacist. Only keep them if the doctor tells you to.

If your medicine appears to be discoloured or shows any other signs of deterioration, please return to your pharmacist who will advise you.

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.

6. contents of the pack and other information

What Macrodantin Capsules contain:

The active substance is nitrofurantoin.

Each hard gelatin capsule contains 50mg nitrofurantoin (in macrocrystalli­ne form).

The other ingredients are: talc, maize starch, lactose monohydrate.

The capsule shell contains: gelatin, sodium lauryl sulphate, quinoline yellow (E104) and titanium dioxide (E171).

The printing ink contains: shellac and black iron oxide (E172).

What Macrodantin Capsules look like and contents of the pack:

Macrodantin are hard gelatin capsules with an opaque yellow cap and opaque white body, marked ‚Eaton 008‘ in black ink on both the cap and the body. The capsules contain a pale yellow powder.

Macrodantin Capsules are available in blister packs of

30 capsules.

Manufacturer

Manufactured by:

Lusomedicamenta S.A., Sociedade Tecnica Farmaceutica, Estrada Consiglieri Pedroso 69B, Queluz de Baixo, 2730–055 Barcarena, Portugal.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder:

Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0574 POM

Leaflet issue and revision date (Ref): 04.05.20

Macrodantin® is a registered trademark of Mercury Pharma Group Limited.

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Product name:

Macrodantin 50mg

Capsules, Hard

Reference No: 21828/0574

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