40 mg / ml oral suspension
metronidazole

1. What Flagyl is and what it is used for

Flagyl (metronidazole) kills certain types of bacteria that live without oxygen (anaerobic bacteria) and also affects infections caused by unicellular organisms ( protozoa ).
Flagyl is used to treat infections caused by certain types of bacteria that live without oxygen (anaerobic bacteria). Flagyl is also used to prevent infection in connection with surgery and further to treat infection caused by certain unicellular organisms ( protozoa ).
Examples of occasions when Flagyl is used: In case of infection in the abdominal cavity; Crohn’s disease in active phase; some infection you in the vagina as well as an infection you emanating from the teeth.

2. What you need to know before taking Flagyl

Do not take Flagyl:

  • if you are allergic (hypersensitive) to metronidazole, similar substances, or to any of the other ingredients of this medicine (see section 6).

Warnings and cautions

With long-term treatment with Flagyl (eg Crohn’s disease ), tingling and numbness in the hands and feet, dizziness, and seizures may occur. Contact a doctor if you get such symptoms.

Flagyl should be used with caution in people suffering from certain diseases of the brain or nervous system.


Flagyl can darken urine, which in itself is harmless. See below for a description of what to do if you experience additional symptoms or suffer from Cockayne’s syndrome.

Flagyl can in rare cases affect the white blood cells so that the immune system deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

Stop taking Flagyl 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.

Cases of severe hepatic/acute liver failure in patients with Cockayne’s syndrome, including fatalities, have been reported with products containing metronidazole.

If you have Cockayne’s syndrome, your doctor should often check your liver function while you are being treated with metronidazole and after treatment.

Stop taking metronidazole and tell your doctor immediately if you get

  • abdominal pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty stools, or itching.

If a widespread, severe rash occurs, with symptoms such as blistering or scaling of the skin, as well as signs of flu and fever ( Stevens-Johnson syndrome ), general malaise, fever, redness of the skin, loosening of the skin and mucous membranes ( toxic epidermal necrolysis ), or redness, scaly rash with lumps under the skin and blisters ( acute generalized exanthematous pustulosis ) you should see a doctor immediately as these skin reactions can be life-threatening.

Other drugs and Flagyl

Treatment with Flagyl may affect or be affected by certain medicines for:

  • alcoholism ( disulfiram )
  • blood clot ( warfarin )
  • manic depressive illness (lithium)
  • organ rejection after transplantation (cyclosporine)
  • epilepsy ( phenytoin, phenobarbital)
  • cancer (5-fluorouracil, busulfan)

The treating physician, therefore, needs to be aware of other concomitant medication, including over-the-counter medication.

Flagyl with food and drink

If alcohol is consumed during treatment with Flagyl, reactions such as nausea, headache, increased heart rate, and feeling hot may occur. Alcohol consumption should therefore be avoided during treatment and at least one day after the end of Flagyl treatment.

Pregnancy and breastfeeding

Limited experience of use during pregnancy. Therefore, consult your doctor before using Flagyl during pregnancy.

Flagyl passes into breast milk. Consult a doctor before taking any medicine while breast-feeding.

Driving and using machines

Confusion, dizziness, hallucinations, seizures, and transient vision changes are rare side effects of Flagyl.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.

Flagyl contains excipients

Flagyl contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Flagyl oral solution contains up to 30 g of sucrose per dose . This should be considered in patients with diabetes mellitus. Sucrose can be harmful to the teeth.

Flagyl contains ethanol

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.

Flagyl contains preservatives

This medicine contains preservatives (methyl parahydroxybenzoate E218, propyl parahydroxybenzoate E216): May cause an allergic reaction (possibly delayed).

3. How to take Flagyl

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you. The size of the dose depends on the type of infection. Even after a couple of days, the problems can subside. However, the treatment must be completed according to the instructions on the pharmacy label. Otherwise, there is a risk that infection will return.

The oral suspension is specially designed for children and people with swallowing difficulties.

The oral suspension also contains sugar. You should therefore take extra care of your toothbrushing and other oral hygiene, especially during long-term treatment with Flagyl oral suspension.

Shaken.

If you take more Flagyl than you should

If you have ingested too much medicine or if a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

4. Possible side effects

Like all medicines, Flagyl can cause side effects, although not everybody gets them.
Common (affects more than 1 in 100 people ): Diffuse symptoms of the gastrointestinal tract such as nausea. A metallic taste in the mouth.

Uncommon (affects less than 1 in 100 people): Decreased white blood cell count ( leukopenia ).

Rare (affects less than 1 in 1,000 people): Fever. Hypersensitivity reaction with fever, rash, local fluid swelling, and drop in blood pressure ( anaphylaxis ). Blood changes such as agranulocytosis, see “Warnings and precautions”. Headache. Tingling and numbness in the hands and feet, dizziness, and seizures. Inflammation of the mouth (oral mucositis), abdominal pain, nausea, vomiting, diarrhea, loss of appetite, taste changes. Inflammation of the pancreas. Skin reactions such as rash, redness, blisters, itching. Swelling of the skin and mucous membranes ( angioedema)), see “Warnings and Precautions”. Hot flashing. Confusion, hallucinations. Transient vision changes. The urine can be temporarily darkened, which is harmless. Liver effects (including jaundice).

Very rare (affects less than 1 in 10,000 patients): Effects on the brain that can confuse, disturbance in the coordination of muscle movements ( ataxia ), speech disorders, involuntary eye movements ( nystagmus ), tremors, and unsteady gait. These side effects disappear when treatment is stopped.

Has been reported (occurs in an unknown number of users): Meningitis. Eye pain ( optic neuritis, optic neuropathy ). Impaired hearing/hearing loss. Tinnitus. Lowered mood. Discoloration or coating on the tongue. Drug-induced skin rash (a rash that recurs in the same place on repeated treatment), widespread, severe skin rash with symptoms such as blistering or scaling of the skin, as well as signs of flu and fever ( Stevens-Johnson syndrome ). General malaise, fever, redness of the skin, loosening of the skin, and mucous membranes ( toxic epidermal necrolysis). Red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis ). See also “Warnings and Precautions”.

The frequency, type, and severity of side effects in children are the same as in adults.
High doses and long-term treatment increase the risk of side effects.
Tell your doctor if you get any side effects.

5. How to store Flagyl

Do not store above 25 ° C.
Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Keep out of sight and reach of children.
The medicine 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 packaging and other information

Content declaration

1 ml oral suspension contains:

  • The active substance is metronidazole 40 mg

The other ingredients are 600 mg sucrose, sodium dihydrogen phosphate, preservatives (methyl parahydroxybenzoate E218, propyl parahydroxybenzoate E216), ethanol (0.96% alcohol content), aluminum magnesium silicate, flavoring (lemon and orange), and water.

What the medicine looks like and the contents of the pack

Glass bottle containing white suspension 100 ml.

Marketing Authorization Holder and Manufacturer

Sanofi AB, Box 30052, 104 25 Stockholm

Muhammad Nadeem

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