Ciprofloxacin Injection USP 200 mg/10Oml

If you have any further questions, ask your doctor or 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• What Metronidazole are and what they are used for.
• What you need to know before you take Metronidazole.
• How to take Metronidazole.
• Possible side effects.
• How to store Metronidazole.
• Contents of the pack and other information.

1. What Metronidazole are and what they are used for

Metronidazole belongs to a group of medicines called antibiotics. It works by killing bacteria and parasites that cause infections in your body. It can be used to:

• Treat infections of the blood, brain, lung, bones, genital tract, pelvic area, stomach and intestines
• Treat gum ulcers and other dental infections 
• Treat infected leg ulcers and pressure sores 
• Prevent infections after surgery.

2. What you need to know before you take Metronidazole. Do not take Metronidazole if:

You are allergic (hypersensitive) to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients in your medicine (listed in Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Do not take Metronidazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Metronidazole.

Take special care with Metronidazole and check with your doctor or pharmacist before using your medicine if:

• You have or have ever had a liver problem.
• You are having kidney dialysis (see section 3: People having kidney dialysis')
• You have a disease of the nervous system.
• If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking your medicine. Do this even if they have applied in the past.
• Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with Metronidazole.
• If you are affected by Cockayne syndrome, your doctor should also monitor your liver function frequently while you are being treated with Metronidazole and afterwards.
• Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthema Tous pustulosis (AGEP) have been reported with the use of Metronidazole.

SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of the mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal. AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever.

 The most common location: mainly localized on the skin folds, trunk, and upper extremities.

The highest risk for occurrence of serious skin reactions is within one week, typically, within 48 hours after start of treatment. If you develop a serious rash or another of these skin symptoms, stop taking Metronidazole and contact your doctor or seek medical attention immediately.

Tell your doctor immediately and stop taking Metronidazole if you develop

Stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic-colored stools or itching.

Other medicines and Metronidazole

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, including herbal medicines.
This is because Metronidazole can affect the way some other medicines work. Also, some other medicines can affect the way Metronidazole works.
In particular tell your doctor if you are taking any of the following medicines:

• Medicines used to thin the blood such as warfarin.
• Lithium for mental illness
• Phenobarbital or phenytoin for epilepsy and fluorouracil for cancer.
• Busulfan for leukemia (cancer of the blood cells) 
• Ciclosporin- to prevent the rejection of organs after transplant Disulfiram for alcoholism.
• If you are not sure, talk to your doctor or pharmacist before taking Metronidazole.

Taking Metronidazole with food and drink

Do not drink any alcohol while you are taking Metronidazole and for 48 hours after finishing your course. Drinking alcohol while using Metronidazole might cause unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heartbeat (palpitations) and headache.

Pregnancy and breast-feeding

• Tell your doctor before using Metronidazole if:
• You are pregnant, might become pregnant or think you may be pregnant.
• Metronidazole should not be taken during pregnancy unless considered absolutely necessary. You are breast-feeding. 
• It is better not to use Metronidazole if you are breast-feeding. This is because small amounts may pass into the mother's milk.

Driving and using machines

While taking Metronidazole you may feel sleepy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions) or temporary eyesight problems (such as blurred or double vision). If this happens, do not drive or use any machinery or tools.

Tests

Your doctor may wish to carry out some tests if you have been using this medicine for more than 10 days.

3. How to take Metronidazole

Always take Metronidazole exactly as your doctor or pharmacist has told you. It is important to finish a full course of treatment. The length of a course will depend on your needs and the illness being treated. Check with your doctor or pharmacist if you are not sure.

• Swallow the tablets whole with a drink of water.
•  Do not crush or chew the tablets.
• Take these tablets during or just after a meal.
• The dose of Metronidazole will depend on your needs and the illness being treated.
• The length of your treatment will depend on the type of illness you have and how bad it is.
• The usual dose for adults and children is given below: To treat bacterial infection Adults.

The initial dose is 800mg. After 8 hours take another dose of 400mg and repeat this dose every 8 hours.

Children: Your doctor will work out how much your child should take depending on their weight. Repeat the dose every 8 hours. If your child is a baby under 8 weeks of age, your doctor will give them one daily dose or two separate doses 12 hourly.

 To prevent infections from happening after surgery

Adults: Start Taking Metronidazole Tablets 24 hours before your operation Take 400 mg of Metronidazole every 8 hours. After the operation you may be given Metronidazole either through a drip into a vein or rectally as a suppository until you are able to take tablets again.

Children: Give your child Metronidazole Tablets 1-2 hours before their operation. Your doctor will work out how much your child should take depending on their weight.
After the operation your child may be given Metronidazole either through a drip into a vein or rectally as a suppository until they are able to take tablets again.

Other types of infections

For treatment of other infections caused by parasites and some bacteria your doctor will decide how much Metronidazole you need to take and how often. This will depend on your illness and how bad it is. The pharmacist's label on the packaging will tell you how many tablets to take and how often to take them.

People having kidney dialysis

Kidney dialysis removes Metronidazole from your blood. If you are having kidney dialysis you must take this medicine after your dialysis treatment.

People with liver problems

Your doctor may tell you to use a lower dose or to use the medicine less often.

If you take more Metronidazole than you should

If you take more Metronidazole than you should, tell your doctor or go to your nearest hospital casualty department straight away. Take the pack and any tablets left with you. This is so the doctor knows what you have taken.

If you forget to take Metronidazole

If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten tablet. Just take the next one when it is due.

4. Possible side effects

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

Stop taking Metronidazole and see a doctor or go to a hospital straight away if:

You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing.

You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).

This may mean you are having an allergic reaction to Metronidazole. A serious but very rare side effect is a brain disease (encephalopathy). Symptoms vary but you might get a fever, stiff neck, headache, see or hear things that aren't there. You might also have problems using your arms and legs, problems with speaking or feel confused. You develop skin rashes including Stevens-Johnson syndrome. Or toxic epidermal necrolysis. These can appear as reddish target-like spots or circular patches often with central blisters on the trunk, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Metronidazole if you develop these symptoms and contact your doctor or seek medical attention immediately. You develop a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalized exanthema Tous pustulosis). Stop using Metronidazole if you develop these symptoms and contact your doctor or seek medical attention immediately.

Talk to your doctor straight away if you notice the following side effects

• Yellowing of the skin and eyes. This could be due to a liver problem.
• Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness. This could be caused by a blood problem.
• Severe stomach pain which may reach through to your back (pancreatitis).

Tell your doctor or pharmacist if you notice any of the following side effects:

• Very rare (affects less than 1 in 10 000 people)
• Fits (convulsions).
• Mental problems such as feeling confused and seeing or hearing things that are not there (hallucinations).
• Problems with your eyesight such as blurred or double vision
• Skin rash or flushing.
• Headache.
• Darkening of the urine.
• Feeling sleepy or dizzy.
• Pains in the muscles or joints.
• Liver problems including life-threatening liver failure (hepatocellular liver injury).
• Not known (frequency cannot be estimated from the available data) Numbness, tingling, pain, or a feeling of weakness, in the arm or legs Unpleasant taste in the mouth.
• Furred tongue.
• Feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhea.
• Loss of appetite Fever.
• Feeling depressed.
• Pain in your eyes (optic neuritis).

A group of symptoms together including fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis).
Hearing impairment/ hearing loss, ringing in the ears (tinnitus).
You get a rash or skin discoloration with or without raised areas which often reoccur at the same location each time the drug is taken.

5. How to store Metronidazole

• Keep out of the reach and sight of children.
• Do not use this medicine after the expiry date which is stated after EXP on the carton and the blister. The expiry date refers to the last day of that month.
• Do not store above 30°C. Store in the original package.
• Do not use this medicine if you notice visible signs of deterioration and 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 protect the environment.

6. Contents of the pack and other information

What Metronidazole contain
The active substance is Metronidazole. Each tablet contains 400 mg of Metronidazole B.P.
The other ingredients are maize starch, lactose, povidone, methylparaben, sodium starch glycollate, magnesium stearate, and tartrazine yellow.

What Metronidazole looks like and contents of the pack?

 Metronidazole is a yellow-colored round flat tablet.

7. Tablets are packed in a blister made of PVC film and Aluminum full Such 3 blisters are packed into a carton along with patient information leaflet.

Manufactured by:
ERNEST CHEMISTS LIMITED PO BOX 3345 Accra, Ghana.
Under license from:
EXETER HEALTH LIMITED Queens gate House, 48, Queen Street, Exeter, Devon EX4 3SR, United Kingdom.