Metronidazole EQL Pharma – Metronidazole uses, dose and side effects


200 mg, 400 mg tablet

What Metronidazole EQL Pharma is and what it is used for

Metronidazole EQL Pharma kills certain types of bacteria that live without oxygen (anaerobic bacteria) and also has an effect against infections caused by unicellular organisms ( protozoa ).

Metronidazole EQL Pharma is used to treat infections caused by certain types of bacteria that live without oxygen (anaerobic bacteria). Metronidazole EQL Pharma is also used to prevent infections associated with surgery and to treat infections caused by certain unicellular organisms ( protozoa ).

Examples of occasions when Metronidazole EQL Pharma is used: In case of infection in the abdominal cavity, Crohn’s disease in the active stage, certain infections in the vagina, and infection that originates from the teeth.

Metronidazole contained in Metronidazole EQL Pharma 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 using Metronidazole EQL Pharma

Do not use Metronidazole EQL Pharma

  • if you are allergic to metronidazole, similar substances or any of the other ingredients of this medicine (listed in section 6)
  • in morbidly altered blood cell composition and ongoing nerve disease at the high dosages recommended in the treatment of infections with non-oxygen-demanding bacteria, certain unicellular organisms , so-called protozoa , and Crohn’s disease

Warnings and cautions

If you experience a severe hypersensitivity reaction (eg anaphylactic shock, see also section 4), discontinue treatment with Metronidazole EQL Pharma and consult a physician immediately.

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

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

Metronidazole EQL Pharma 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.

Metronidazole EQL Pharma may in rare cases affect the white blood cells so that the defense against infection 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/throat/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.

Stop taking Metronidazole EQL Pharma and contact your 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 check your liver function frequently during and after treatment with metronidazole.

Stop using Metronidazole EQL Pharma and tell your doctor immediately if you get stomach 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, reddening of the skin, loosening of 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 medicines and Metronidazole EQL Pharma

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

Treatment for Metronidazole EQL Pharma may affect or be affected by certain medicines for:

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

Metronidazole EQL Pharma with food, drink and alcohol

If alcohol is taken during treatment with Metronidazole EQL Pharma, 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 treatment.

Pregnancy, breastfeeding and fertility

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.

Limited experience with the use of Metronidazole EQL Pharma during pregnancy. Metronidazole is therefore not recommended during pregnancy or in women of childbearing potential not using contraception. Talk to your doctor before using Metronidazole EQL Pharma during pregnancy.

Metronidazole EQL Pharma passes into breast milk. Consult a doctor before using the medicine during breastfeeding. Breast-feeding should be discontinued during treatment with Metronidazole EQL Pharma. After the end of treatment, breastfeeding should not be started until after a further 3 days.

Driving and using machines

Confusion, dizziness, hallucinations, seizures, and transient vision changes are rare side effects of Metronidazole EQL Pharma.

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.

How to use Metronidazole EQL Pharma

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

The tablets should be swallowed.

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 of treatment, the problems can subside. However, the course of Metronidazole EQL Pharma must be completed according to the instructions. Otherwise, there is a risk of infection recurring.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If severe allergic reaction with fever, rash, local swelling caused by fluid, and low blood pressure occurs, stop using Metronidazole EQL Pharma and contact a doctor immediately.

If you develop any of the following (symptoms of angioedema ), stop using Metronidazole EQL Pharma and contact your doctor immediately:

  • Swelling of the face, tongue or throat
  • Difficulty swallowing
  • Hives and difficulty breathing

If you develop any of the following, consult a doctor immediately as these skin reactions can be life-threatening:

  • Widespread, severe rash with blistering or scaling of the skin, signs of flu and fever (Steven-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 )

Common (may affect more than 1 in 100 people):

Diffuse symptoms from the gastrointestinal tract such as nausea. A metallic taste in the mouth.

Uncommon (may affect less than 1 in 100 people):

Reduction in the number of white blood cells ( leukopenia ).

Rare (may affect less than 1 in 1,000 people):

Fever. Hematological changes such as agranulocytosis, see section “Take special care with Metronidazole EQL Pharma” in section 2. Headache. Tingling and numbness in the hands and feet, dizziness, and seizures. Inflammation of the mouth (oral mucositis), pain in the pit of the stomach, nausea, vomiting, diarrhea, loss of appetite, changes in taste. Inflammation of the pancreas. Skin reactions such as rash, redness, blisters, itching. Hot flashing. Confusion, hallucinations. Transient vision changes. The urine may darken on occasion, which is harmless. Liver effects (including jaundice).

Very rare (may affect less than 1 in 10,000 patients):

Impact on the brain that can confuse, disturbance in the coordination of muscle movements ( ataxia ), speech disturbance, 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):

Superinfection with candida (eg sexually transmitted diseases). Meningitis. Eye pain ( optic neuritis, optic neuropathy ). Impaired hearing/hearing loss. Tinnitus. Lowered mood. Discoloration or coating on the tongue.

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.

How to store Metronidazole EQL Pharma

Do not store above 30 ° C

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 or label after EXP. The expiration date is the last day of the specified month.

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 pack and other information

Content declaration

– The active substance is metronidazole. Each tablet contains 200 mg or 400 mg.

The other ingredients are calcium hydrogen phosphate, maize starch, povidone, maize starch, and magnesium stearate. Film cover: hypromellose and macrogol.

What the medicine looks like and contents of the pack

Metronidazole EQL Pharma 200 mg are white, round (diameter about 9 mm) tablets.

Metronidazole EQL Pharma 400 mg are white, capsule-shaped (length about 17 mm, width about 7 mm) tablets.

200 mg tablets:

Blister pack of 21 tablets

400 mg tablets:

Blister pack of 14, 20, and 30 tablets respectively

Plastic jar HDPE with 100 and 105 tablets respectively.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Germany: Metronidazole EQL Pharma

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