Nitrofurantoin Synchrony pharma 100mg Prolonged-release capsules – patient leaflet, side effects, dosage

1. What Nitrofurantoin Synchrony pharma is and what is it used for

1. 2. What do you need to know before you take Nitrofurantoin Synchrony pharma
2. 3. How to take Nitrofurantoin Synchrony pharma
3. 4. Possible side effects
4. 5. How to store Nitrofurantoin Synchrony pharma
5. 6. Contents of the pack and other information
6. 1. What Nitrofurantoin Synchrony pharma is and what is it used for

Nitrofurantoin, the active substance in Nitrofurantoin Synchrony pharma is an antibiotic.

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

2. What do you need to know before you take Nitrofurantoin Synchrony pharma

Do not take Nitrofurantoin Synchrony pharma

• if you are allergic to nitrofurantoin, other nitrofurans or 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 have porphyria (blood disorder)
• if you have G6PD (glucose-6-phosphate dehydrogenase) deficiency
• do not use in infants 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 Nitrofurantoin Synchrony pharma

• 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); 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.
• if you have disease of the lungs

This medicine can also cause lung disease in patients with no previous medical history affecting their lungs. Lung disease can occur in patients on short-term or long-term treatment. Talk to your doctor if you experience trouble breathing, shortness of breath, a lingering cough, coughing up blood or mucus, or pain or discomfort when breathing. These may be symptoms of side effects affecting the lungs.

The above conditions may increase the chance of developing a side effect which causes damage to the nerves, altered sense of feeling, like 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 Nitrofurantoin Synchrony pharma for a number of months, your doctor may want to regularly check how your lungs and liver are working
• if you have false positive results on testing your urine for glucose
• if you have urine coloured 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 gray-colored stools. It may be symptoms of liver disorder.

Other medicines and Nitrofurantoin Synchrony pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If they are taken with Nitrofurantoin Synchrony pharma their effect or the effect of Nitrofurantoin Synchrony pharma may be changed.

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

• antacids for indigestion (containing magnesium trisilicate)
• medicines for gout (such as probenecid or sulfinpyrazone)
• medicines for raised pressure in the eye (glaucoma), such as carbonic anhydrase inhibitors (such as acetazolamide)
• medicines which make the urine less acidic (such as potassium citrate mixture)
• medicines for infections, known as quinolones
• carbonic anhydrase inhibitors (such as acetazolamide for the treatment of glaucoma).
• the oral typhoid vaccine which is given for the prevention of typhoid

If you are not sure about any of these medicines, consult your doctor or pharmacist.

Nitrofurantoin Synchrony pharma with food and drink

Nitrofurantoin Synchrony pharma should be taken at meal times with food or with a dairy product, such as milk or yogurt. This will help to avoid stomach upset and also to help the absorption.

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.

As far as it is known, nitrofurantoin may be used during pregnancy.

However, this medicine 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, consult with your doctor first.

Driving and using machines

Nitrofurantoin Synchrony pharma may cause dizziness and drowsiness (sleepiness). You should not drive or operate machinery if you are affected this way until such symptoms go away.

Nitrofurantoin Synchrony pharma contains lactose and sucrose

This medicine contains lactose and sucrose which are types of sugars. If you have been told by your doctor that you have an intolerance to some sugars and have to avoid them, contact your doctor before taking this medicine.

3. How to take Nitrofurantoin Synchrony pharma

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

The recommended dose is:

Adults and children over 12 years old:

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 bladder infections: One capsule twice a day for seven days
• for prevention of bladder infections during surgery: One capsule twice a day on the day of the operation and three days thereafter.

Use in children

Nitrofurantoin Synchrony pharma is not recommended for children under 12 years of age.

Nitrofurantoin Synchrony pharma should be taken with food or milk.

Medical Checks:

Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system. Nitrofurantoin Synchrony pharma may interfere with the results of some tests for glucose in the urine.

Method of administration

Capsules should be swallowed whole.

If you take more Nitrofurantoin Synchrony pharma 100mg Prolonged-release capsules than you should

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

If you forget to take Nitrofurantoin Synchrony pharma

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 Nitrofurantoin Synchrony pharma 100mg Prolonged-release 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 usually disappear when you stop taking Nitrofurantoin Synchrony pharma 100mg Prolonged-release capsules. If you experience any of the side effects detailed below, or any other side effects, stop taking this medicine and consult your doctor or pharmacist.

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.

Be aware that while taking Nitrofurantoin Synchrony pharma your urine may become coloured dark yellow or brown. This is quite normal and it not a reason to stop taking the medicine.

If you notice any of the following side effects, consult your doctor immediately:

• Your lungs may react to Nitrofurantoin Adalvo. 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 associated with pneumonia. Scaring due to damaged lung tissue may occur
• Nitrofurantoin Synchrony pharma may cause the liver to become inflamed, producing jaundice (yellowing of the skin or whites of the eyes).
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely
• Blue or purple coloration 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 fatigue, abdominal pain, joint pain and swelling. These could be signs of a condition known as hepatitis. In rare cases, it may cause liver failure which may be fatal.

Other side effects are:

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

• Loss of consciousness (collapse)
• Damage to bone marrow causing deficiency of the red blood cells (anaemia).

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

• Feeling sick (nausea) and headache
• Loose stools
• Loss of appetite, stomach ache, and being sick (vomiting)
• Diarrhoea
• Dizziness, drowsiness (sleepiness)
• 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
• 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
• 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 gland (causing severe abdominal pain) and joint pains
• Short-term hair loss
• Raised pressure in the skull (causing severe headaches)
• Urinary infection by germs which are not sensitive to this medicine
• 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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 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 Nitrofurantoin Synchrony pharma 100mg Prolonged-release capsules

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

Do not store Nitrofurantoin Synchrony pharma above 25 °C.

Do not use this medicine after the expiry date (EXP) which is stated on the carton and/or blister. 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 package and other information

What Nitrofurantoin Synchrony pharma 100mg Prolonged-release capsules contains

• The active substance in this medicine is nitrofurantoin. Each prolonged-release capsule contains equivalent of 100mg nitrofurantoin in the form of nitrofurantoin macrocrystals and nitrofurantoin monohydrate.

• The other ingredients are:

  • capsule content: talc, maize starch, carbomer, povidone, lactose monohydrate, sucrose (see section 2 Nitrofurantoin Synchrony pharma contains lactose and sucrose), magnesium stearate.
  • capsule shell: iron oxide yellow, iron oxide black, titanium dioxide), Indigo Carmine (E 132), gelatin.
  • printing ink: shellac, propylene glycol (E 1520), strong ammonia solution, water, potassium hydroxide, titanium dioxide (E 171).

What Nitrofurantoin Synchrony pharma looks like and contents of the pack

Nitrofurantoin Synchrony pharma are approximately 19 mm long and 7 mm wide capsules with blue opaque cap imprinted with “NTRF” in white ink and yellow opaque body.

Nitrofurantoin Synchrony pharma is supplied in carton boxes containing 2, 14 or 20 capsules in PVC-Aclar/aluminium blisters.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Synchrony Pharma Limited,

3 Bunhill Row,

London,

EC1Y 8YZ,

United Kingdom

Manufacturer

KeVaRo Group Ltd.

9 Tzaritza Elenora Str. Office 23

Sofia 1618, Bulgaria

This leaflet was last revised in {06/2025}