Patient leaflet - Vaginyl/metronidazole tablets 200 mg
1. WHAT VAGINYL IS AND WHAT IT IS USED FOR
The name of this medicine is Vaginyl 200 mg tablets (called as Vaginyl in this leaflet). Vaginyl contains a medicine called Metronidazole. This is 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, bone, genital tract, pelvic area, stomach and intestines
- Treat gum ulcers or other dental infections
- Treat infected leg ulcers or pressure sores
- Prevent infections after surgery
If you need any further information on your illness, speak to your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VAGINYL
Do not take Vaginyl if:
- you are allergic to metronidazole, or to any of the ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue.
Do not take Vaginyl if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Vaginyl.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Vaginyl 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.
Tell your doctor immediately and stop taking Vaginyl if you develop: stomach pain, anorexia (loss of appetite), nausea (feeling sick), vomiting (being sick), fever, malaise, fatigue, vertigo (spinning sensation), jaundice, dark urine, putty or mastic-coloured stools or itching.
Cases of severe liver toxicity/acute liver failure, including cases with fatal outcomes. in patients with Cockayne Syndrome have been reported with Vaginyl. If you are affected by Cockayne syndrome, your doctor should also monitor your liver function frequently while you are being treated with Vaginyl and afterwards.
Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP) have been reported with the use of Vaginyl:
- 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 localised 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 Vaginyl and contact your doctor or seek medical attention immediately.
Other medicines and Vaginyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Vaginyl can affect the way some other medicines work.
Also, some other medicines can affect the way Vaginyl works.
In particular tell your doctor if you are taking any of the following medicines:
- medicine used to thin the blood such as Warfarin
- lithium for mental illness
- phenobarbital or phenytoin for epilepsy
- 5-florouracil for cancer
- busulfan for leukaemia (cancer of the blood cells)
- ciclosporin to prevent the rejection of organs after transplant
- disulfiram for alcohol
If you are not sure, talk to your doctor or pharmacist before taking Vaginyl.
Vaginyl with alcohol
Do not drink any alcohol while you are taking Vaginyl and for 48 hours after finishing your course. Drinking alcohol while using Vaginyl might cause an unpleasant side effect. such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heartbeat (palpitations) and headache.
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.
- Vaginyl should not be taken during pregnancy unless considered absolutely necessary.
- You are breast-feeding. It is better not to take Vaginyl if you are breast-feeding. This is because small amounts may pass into the mother’s milk.
Driving and using machines
While using Vaginyl you may feel dizzy or experience vertigo (spinning sensation), confusion, hallucinations (seeing or hearing things that are not there), convulsions (fits) 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
3. HOW TO TAKE VAGINYL
Always take this medicine 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.
Taking this medicine:
- swallowed the tablet whole with a drinking of water
- do not crush or chew the tablets.
- take these tablets during or just after a meal.
- the dose of Vaginyl 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 recommended dose is:
To treat bacterial infection
Adults:
- The initial dose is 800 mg.
- After 8 hours take another dose of 400 mg and repeat this every 8 hour.
Use in 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 Vaginyl tablets 24 hours before your operation.
- Take 400 mg every 8 hours.
- After the operation you may be given Vaginyl either through a drip into a vein or rectally as a suppository until you are able to take tablets again.
Children:
- Give your child Vaginyl 1-2 hours before the operation
- Your doctor will work out how much your child based on your child should take depending on their weight.
- After the operation your child may be given Vaginyl 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 the treatment of other infections caused by parasites and some bacteria your doctor will decide how much Vaginyl 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 Vaginyl 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 take the medicine less often.
If you take more Vaginyl than you should
If you take more Vaginyl 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 Vaginyl
If you forget to take Vaginyl, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Vaginyl and see a doctor or go to a hospital straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
- You have an allergic reaction. The signs may include swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing, an itchy, lumpy rash (hives) or nettle rash (urticaria).
- A serious but very rare side effect is a brain disease (encephalopathy). Symptoms vary but you might get a fever, stiff neck, headache, or 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 Vaginyl if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.
- You develop a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Vaginyl if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.
- Yellowing of the skin and eyes. This could be due to a liver problem (jaundice).
- 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 any of the following side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet:
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)
- Acute liver failure in patients with Cockayne Syndrome (see section 2 “Warnings and precautions”)
- numbness, tingling, pain, or a feeling of weakness, in the arms or legs
- unpleasant taste in the mouth, furred tongue
- feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhoea
- 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)
- vertigo (spinning sensation)
- you get a rash or skin discoloration with or without raised areas which often reoccurs at the same location each time the drug is taken
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 affects you can help provide more information on the safety of this medicine.
5. HOW TO STORE VAGINYL
Keep this medicine out of the sight and reach of children.
Store in a dry place below 25ºC in well closed containers. Protect from light.
Do not use this medicine after the expiry date, which is stated on the container after EXP. The expiry date refers to the last day of 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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Vaginyl Tablets contain
The active substance is Metronidazole BP
Each tablet contains either 200 mg, Metronidazole BP.
Other ingredients for 200 mg tablets: Lactose, Maize starch, Pregelatinised maize starch, Sodium starch glycollate, Magnesium stearate.
What Vaginyl Tablets look like and contents of the pack
VAGINYL tablets are round, white, bevelled edge, engraved VAGINYL on one side, with a break-line on the other.
VAGINYL is available in plastic containers of 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 140, 150, 168, 180, 500, 1000, 5000 and 50,000 tablets.
Marketing Authorisation Holder
Chelonia Healthcare Ltd.
Boumpoulinas 11, 3rd Floor, Nicosia, P.C.1060 CYPRUS
The manufacturer of VAGINYL tablets is:
DDSA Pharmaceuticals Ltd.
310 Old Brompton Road, London SW5 9JQ.
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.