Patient leaflet - METROLYL (METRONIDAZOLE) TABLETS 400 MG, METRONIDAZOLE 400 MG TABLETS
Sandoz Ltd
______December 2016
PL 04416/0060 & 0061
Metrolyl (Metronidazole) Tablets 200mg and 400mg
Taking your Medicine
Recommended doses follow. Doctors sometimes prescribe different doses to these: if this applies to you, discuss it with the doctor, if you have not already done so. You should always follow your doctor’s instructions as to when and how to take your medicine. Your pharmacist may be able to advise if you are not sure. Exactly how many tablets and when to take them will be written on the label. Please read it carefully.
Treatment with metronidazole will normally be for 7 days. Shorter or longer treatment may be prescribed if your doctor feels this is necessary. If treatment is to continue for longer than 10 days your doctor will keep a close eye on you. You should continue and complete the course of metronidazole prescribed for you even if you are feeling better.
Metrolyl® (Metronidazole) Tablets should be swallowed with a drink of water during or after a meal.
The normal daily doses are as follows.
For the treatment of infections
Metronidazole Tablets may be given on their own or with other medicines which kill bacteria.
| General dosage Adults : | 400mg, 3 times a day. |
| Children 8 weeks to 12 years: | 20–30mg of metronidazole for each kilogram of the child’s body weight a day or 7.5mg of metronidazole for each kilogram of the child’s weight every 8 hours, for 7 days |
| Children under 8 weeks: | 15mg of metronidazole for each kilogram of the child’s body weight a day or 7.5mg of metronidazole for each kilogram of the child’s body weight every 12 hours. |
If you have liver problems, your dose may be reduced to one-third of the normal dosage, once a day.
For patients with urogenital infections
Sexual partners should be treated concurrently.
| Adults and children over 10 years : | 200mg, 3 times a day for 7 days or 400mg twice a day for 5–7 days, or 2,000mg once. |
| Children under 10 years : | 40mg of metronidazole for each kilogram of the child’s body weight once or 15–30mg of metronidazole for each kilogram of the child’s body weight, in 2–3 doses, for 7 days. |
| In bacterial infections of the vagina Adults and children over 10 years : | 400mg twice a day for 5–7 days or 2,000mg once as a single dose. |
Dysentery/amoebiasis: invasive intestinal disease
| Adults and children over 10 years : | 800mg, 3 times a day for 5 days. |
| Children : 7 to 10 years: | 400mg, 3 times a day for 5 days. |
| 3 to 7 years: | 200mg, 4 times a day for 5 days. |
| 1 to 3 years: | 200mg, 3 times a day for 5 days. |
Dysentery/amoebiasis: intestinal disease and chronic amoebic hepatitis
Adults and children over 10 years : 400mg, 3 times a day for 5 to 10 days.
| Children : 7 to 10 years: | 200mg, 3 times a day for 5 to 10 days. |
| 3 to 7 years: | 100mg, 4 times a day for 5 to 10 days. |
| 1 to 3 years: | 100mg, 3 times a day for 5 to 10 days. |
| PIL.0060–61.005.0d | V018: Updated PIL and SPC in line with PRAC recommendations | SL |
| Sandoz Ltd | December 2016 |
| Metrolyl (Metronidazole) Tablets 200mg and 400mg | PL 04416/0060 & 0061 |
Dysentery/amoebiasis: amoebic liver abscess and other forms of extra-intestinal amoebiasis
| Adults and children over 10 years : | 400mg, 3 times a day for 5 days. |
| Children : 7 to 10 years: | 200mg, 3 times a day for 5 days. |
| 3 to 7 years: | 100mg, 4 times a day for 5 days. |
| 1 to 3 years: | 100mg, 3 times a day for 5 days. |
Dysentery/amoebiasis: in patients who have passed cysts but who are otherwise symptomless
| Adults and children over 10 years : | 400mg to 800mg, 3 times a day for 5 to 10 days. |
| Children : 7 to 10 years: | 200mg to 400mg, 3 times a day for 5 to 10 days. |
| 3 to 7 years: | 100mg to 200mg, 4 times a day for 5 to 10 days. |
| 1 to 3 years: | 100mg to 200mg, 3 times a day for 5 to 10 days. |
| For giardiasis Adults and children over 10 years : | 2,000mg, once a day for 3 days, or 400mg 3 times a day for 5 days, or 500mg twice a day for 7–10 days. |
| Children : 7 to 10 years: | 1,000mg, once a day for 3 days. |
| 3 to 7 years: | 600mg to 800mg, once a day for 3 days. |
| 1 to 3 years: | 500mg, once a day for 3 days. |
For gum disease (acute ulcerative gingivitis)
| Adults and children over 10 years : | 200mg, 3 times a day for 3 days. |
| Children : 7 to 10 years: | 100mg, 3 times a day for 3 days. |
| 3 to 7 years: | 100mg, twice a day for 3 days. |
| 1 to 3 years: | 50mg, three times a day for 3 days. |
| For acute dental infections Adults and children over 10 years : | 200mg, 3 times a day for 3 to 7 days. |
| For leg ulcers and pressure sores Adults and children over 10 years : | 400mg, 3 times a day for 7 days. |
| For the treatment of H.pylori infections Children: | 20mg of metronidazole a day for each kilogram of the child’s body weight for 7–14 days. |
For the prevention of infections
| In gynaecological surgery Adults and children over 12 years : | 1,000mg as a single dose, followed by 200mg, 3 times a day until preoperative withholding of solids and liquids by mouth becomes necessary. 200mg, 3 times a day should be resumed after the operation and for a period of up to 7 days. |
| Children under 12 years: | 20–30mg of metronidazole for each kilogram of the child’s body weight 1–2 hours before surgery. |
| Newborns: | 10mg of metronidazole for each kilogram of the child’s body weight before surgery. |
As a pre-operative medication prior to surgery on your colon
| Adults and children over 12 years : | 200mg every 6 hours, with an aminoglycoside antibiotic for 3 days before surgery |
| PIL.0060–61.005.0d | V018: Updated PIL and SPC in line with PRAC recommendations | SL |
| Sandoz Ltd | December 2016 |
| Metrolyl (Metronidazole) Tablets 200mg and 400mg | PL 04416/0060 & 0061 |
or
400mg every 8 hours with phthalylsulphathiazole (2,500mg every 6
hours) for 4 days before your operation.
Children under 12 years:
Newborns:
20–30mg of metronidazole for each kilogram of the child’s body
weight 1–2 hours before surgery.
10mg of metronidazole for each kilogram of the child’s body weight before surgery.
If you forget to have a dose, take the missed dose as soon as you remember. If your next dose is due within 2 hours, have a single dose straight away and skip the next.
If you take an unintentional extra dose, this should not cause problems. If you or someone else has taken too many tablets or a large overdose has been taken, seek medical help immediately.
As with all medicines, metronidazole may cause unwanted effects in some people, although serious reactions are rare. An unpleasant taste in the mouth, furred tongue, nausea, vomiting or other gastro-intestinal disturbance has been reported.
Occasionally, you may feel drowsy, dizzy, have a headache and feel shaky or unsteady while taking metronidazole.
Hypersensitivity reaction can occur including skin rashes, including nettle rash, or itching. Rarely, a more severe allergic reaction can occur called angioedema, symptoms of which are large, well-defined swellings which suddenly occur in the skin, particularly around the face and throat. Extremely rarely, a very severe allergic reaction called anaphylaxis may occur. Symptoms of this may be lowered blood pressure (making you feel dizzy or light-headed), itchy raised rash, tightness in the chest and breathing difficulties, swelling of the tongue or throat, pain in the stomach and diarrhoea. If any of these rare reactions occur, contact your hospital accident and emergency department immediately.
Peripheral neuropathy (a disease of the peripheral nerves, symptoms of which are general weakness and numbness) and/or convulsions or fits have occurred during prolonged or intensive treatment with metronidazole. In most cases peripheral neuropathy disappears when treatment is stopped.
Changes to your blood may occur (red cells, white cells, platelets, etc). If there is a tendency to bruise easily, you notice bleeding into the skin, prolonged bleeding, bleeding from the gums or elsewhere, or you feel tired and look pale, stop taking the medicine and see your doctor.
Rarely patients may develop liver disease and jaundice (yellowing of the skin and the whites of the eyes), or darkening of the urine.
If you have any of these effects and they become worse, inconvenient or upsetting; see your doctor or pharmacist. If you experience any other unpleasant effects which you think could be caused by this medicine you should contact your doctor or pharmacist for advice.
Storing your Medicine
Do not use Metrolyl® (Metronidazole) Tablets BP 200mg or 400mg after the expiry date shown on the label. Any out of date medicines should be returned to your pharmacist for disposal.
Do not store above 25°C. Store in the original container.
If you notice any defects in the tablets, such as chips or broken tablets, take them to your pharmacist for advice before taking them.
Date of revision: 13/12/2016
| PIL.0060–61.005.0d | V018: Updated PIL and SPC in line with PRAC recommendations | SL |
| Sandoz Ltd | December 2016 |
| Metrolyl (Metronidazole) Tablets 200mg and 400mg | PL 04416/0060 & 0061 |
Keep all medicines out of the reach and sight of children. Your medicines can harm them.
REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others it may harm them even if their symptoms are the same as yours.
This leaflet only applies to Metrolyl® (Metronidazole) Tablets BP 200mg or 400mg.
® trade mark
| PIL.0060–61.005.0d | V018: Updated PIL and SPC in line with PRAC recommendations | SL |