50 mg nitrofurantoin tablets
What Nitrofurantoin Alternova is and what it is used for
Nitrofurantoin Alternova contains nitrofurantoin, which has a bactericidal effect. It is effective against most bacterial species that cause urinary tract infections.
Nitrofurantoin Alternova is used to treat urinary tract infections.
Nitrofurantoin contained in Nitrofurantoin Alternova may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Nitrofurantoin Alternova
Do not use Nitrofurantoin Alternova
- if you are allergic to nitrofurantoin or any of the other ingredients of this medicine (listed in section 6)
- when breastfeeding children under 1 month of age
- if you know you are deficient in the enzyme glucose – 6 -phosphate dehydrogenase
- if you have severe renal impairment
- should not be given to newborns or children under 1 month of age.
Warnings and cautions
Talk to your doctor or pharmacist before using Nitrofurantoin Alternova.
If you have the following diseases, you should consult a doctor before starting treatment with Nitrofurantoin Alternova:
- renal impairment
- anemia (too little red blood cell )
- diabetes ( diabetes mellitus )
- electrolyte disturbances (disturbances in the salt balance)
- Vitamin B deficiency
Sometimes the urine can turn brown, but it is completely harmless.
You should stop taking Nitrofurantoin Alternova and contact a doctor immediately if you get any of the following symptoms ( angioedema ):
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing
Talk to your doctor if you experience fatigue, yellowed skin or eyes, itching, rash, joint pain, abdominal discomfort, nausea, vomiting, loss of appetite, dark urine, and pale or gray stools. This may be a symptom of liver disease.
Other medicines and Nitrofurantoin Alternova
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Nitrofurantoin Alternova may affect the results of certain tests for glucose (sugar) in the urine.
Nitrofurantoin Alternova with food and drink
Nitrofurantoin Alternova should be taken with food to reduce nausea and to improve the effect. The tablets can be crushed and mixed in a little liquid or mixed in the food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Immediately following delivery, Nitrofurantoin Alternova should be given only after special consideration by your doctor.
Breast-feeding
Nitrofurantoin Alternova passes into breast milk. Do not use Nitrofurantoin Alternova when breastfeeding children under 1 month of age.
Driving and using machines
Nitrofurantoin Alternova has no known effects on the ability to drive and use machines.
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.
Nitrofurantoin Alternova contains lactose
Nitrofurantoin Alternova contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Nitrofurantoin Alternova
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults
Dose one is determined by the doctor, who adjusts it individually for you. The usual dose range is 50 mg 3 times daily for 5 days.
Use for children
Nitrofurantoin Alternova 50 mg tablet is not suitable for children. Other suitable strengths and dosage forms containing nitrofurantoin should be used instead.
Nitrofurantoin Alternova should be taken with food to reduce nausea and to improve the effect. The tablets can be crushed and mixed in a little liquid or mixed in the food.
In recurrent urinary tract infections, long-term treatment for several months and even years is often necessary. It is important to complete the medication according to the doctor’s prescription to prevent infection from recurring.
The tablet can be divided into two equal doses.
If you use more Nitrofurantoin Alternova than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Nitrofurantoin Alternova
Do not take a double dose to make up for a forgotten dose.
If you stop using Nitrofurantoin Alternova
Do not stop taking Nitrofurantoin Alternova unless your doctor tells you to. You must complete the medication according to your doctor’s prescription to prevent a recurrence of infection.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if the following serious side effects occur:
A severe allergic reaction that may be rare (affects less than 1 user in 1,000) and severe. Symptoms of an allergic reaction ( angioedema ) may include swelling of the face, lips, tongue, or throat, sometimes with shortness of breath or difficulty swallowing.
Very severe hypersensitivity reactions have been reported (occurring in an unknown number of patients) and may be severe. Symptoms of a severe hypersensitivity reaction (anaphylactic shock ) may include fever, rash, swelling, and sometimes a drop in blood pressure.
The disease “SLE” ( chronic rheumatic disease) is rare (occurs in less than 1 in 1000 patients). Symptoms include shortness of breath, fever, fatigue, rash, itching, headache.
Other side effects may occur:
Uncommon (affects less than 1 patient in 100):
- nausea and vomiting, especially at higher doses and if the drug is taken on an empty stomach
- headache
- dizziness
- diarrhea
- lung and respiratory problems with asthma-like symptoms such as difficulty breathing and shortness of breath
- dry mouth
- muscle pain
- external nerve damage with symptoms such as crawling and numbness in the feet and hands
- hepatic impairment (jaundice) and haematological changes with elevated liver enzymes (no symptoms) may occur
- rash
- itching
- fever
Rare (affects less than 1 in 1,000 people):
- difficulty fixing the gaze
- hair loss
- benign pressure increase inside the skull
- mumps
- pathological increase of tissue in the lungs during long-term treatment
No known frequency (affects the unknown number of patients):
- abdominal pain
- inflammation of small blood vessel walls, causing skin conditions
- hepatitis as a result of the immune system’s effect on liver cells
- renal tissue inflammation with surrounding tubules, which causes renal impairment.
How to store Nitrofurantoin Alternova
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 and blister. The expiration date is the last day of the specified month.
No special storage instructions.
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 package and other information
Content declaration
- The active substance is nitrofurantoin
- Other ingredients are:Lactose monohydrateCorn starchPovidonMagnesium stearate
What the medicine looks like and contents of the pack
Nitrofurantoin Alternova tablets: Yellow, round, biconvex tablets, diameter 8 mm. with break notch on one side.
Blister pack of PVC / ALU: 15, 50, 100, and 105 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alternova A / S
Lodshusvej 11
4230 Skælskør
Denmark
Manufacturer:
IASIS Pharmaceuticals GREECE SA – Koropi
Archimedes street
Koropi Attikis, 19 400
Greece