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NITROFURANTOIN 100 MG CAPSULES, MACRODANTIN 100 MG CAPSULES - patient leaflet, side effects, dosage

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Patient leaflet - NITROFURANTOIN 100 MG CAPSULES, MACRODANTIN 100 MG CAPSULES

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.

This product will be referred to as Macrodantin Capsules for ease hereafter.

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 if you are allergic to nitrofurantoin, other nitrofurans 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);

Macrodantin Capsules contains lactose

If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicine.

Information on sodium content

This medicine contains less than 1 mmol sodium (23 mg) 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: Either one 50mg capsule or one 100mg capsule four times a day for seven days
  • For prevention of further infections: Either one 50mg capsule or one 100mg 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.

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.

  • A ■ ■ ■

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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side-effects you can help provide more information on the safety of this medicine

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 to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP:. The expiry date refers to the last day of that month.

Do not throw away any medicines 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.

6. contents of the pack and other informationthe active substance is nitrofurantoin. macrodantin capsules are available in two strengths, containing either 50mg or 100mg nitrofurantoin.

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 looks like and contents of the pack:

Macrodantin 50mg capsule is a no. 3 size hard gelatin capsule with an opaque yellow cap and white opaque body. The capsules are printed in edible black ink and bears the monogram “Eaton 008”.

Macrodantin 100mg capsule is a no. 2 size hard gelatin capsule with an opaque yellow cap and yellow opaque body. The capsules are printed in edible black ink and bears the monogram “Eaton 009”. The capsules are available in blister packs of 30.

Marketing Authorisation Holder: Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Manufacturer

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

This leaflet was last revised in April 2021.

Macrodantin is the registered trademark of Mercury Pharma Group Limited.