Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ovex
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Mebendazole may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for This medicine is for use in adults and children aged over 2 years.
Adults and children aged 2 years and older
If any of the bullet points apply to you now or in the past, talk to a doctor or pharmacist.
This medicine is used to treat threadworm infections of the gut. ■ This medicine is for use by adults and children aged over 2 years. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. ■ Keep this leaflet. You may need to read it again. ■ Ask your pharmacist if you need more information or advice. ■ If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. ■ You must talk to a doctor if you do not feel better or if you feel worse after a few days. ■
CHILD
Project Name / Design UK Ovex Tablets PIL PiQ & Excipient (SNAS 3382)
If you are taking any other medicines, including: ■ Metronidazole (a drug used to treat bacterial and protozoan infections) as a serious skin reaction can rarely occur. ■ Cimetidine (a medicine used to treat excess stomach acidity).
Very rare: (may affect up to 1 in 10,000 people) ■ Inflammation of the kidneys* ■ Decrease in bone marrow* activity resulting in reduced production of blood cells ■ Nausea ■ Vomiting *observed in higher and prolonged doses
Reporting of side-effects If you experience any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible
What you need to know before you take it
e this medicine
Age
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Do not take this medicine if you are pregnant. Ask your doctor or pharmacist for advice before taking this medicine if you are breast-feeding.
How to take it
this medicine Check the table that follows to see how much medicine to take.
Common: (may affect up to 1 in 10 people) ■ Stomach pain
This medicine is a single-tablet dose. Do not take more than the stated dose shown below. For oral use only. ■ The tablet may be either chewed or swallowed whole. Crush the tablet before giving it to a young child. ■ Always supervise a child if they are taking this medicine. ■ Ovex Suspension could be considered for young children who are unable to swallow the Ovex Tablet.
Uncommon: (may affect up to 1 in 100 people) ■ Stomach discomfort ■ Diarrhoea ■ Wind
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Other effects that may occur include: Rare: (may affect up to 1 in 1,000 people) ■ Inflammation of the liver or abnormal liver function ■ Reduction in white blood cells (which reduces the body's defences against infections) ■ Unusual hair loss ■ Dizziness.
This medicine is not recommended for children aged under 2 years. It should be given to children aged 1-2 years only under medical supervision and if there are no suitable alternatives.
Fonts used
ArtWorks ID
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P160815C
Rare: (may affect up to 1 in 1,000 people) Convulsions (seizures/fits). ■ Allergic reactions including unexplained wheezing, shortness of breath, sudden swelling of your face or throat, and hives (also known as 'nettle rash' or 'urticaria'). ■ Skin rashes (which may be severe and include blistering or peeling of the skin) and itching, and may be accompanied by a high temperature.
Some of the ingredients can cause problems
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If you experience any of the following, stop using the medicine and seek immediate medical help:
FPO Old Component / Item Code
Like all medicines, Ovex can cause side-effects, although not everybody gets them.
FPO
New Component / Item Code
4 Possible side-effects
Since threadworms can spread very easily, it is strongly recommended that all the family (except pregnant, breast-feeding women or children under 2) are treated at the same time and that suitable hygiene precautions are followed to prevent re-infection (see Section 7 of this leaflet for more advice).
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You must talk to a doctor if you do not feel better or if you feel worse after a few days. If you are re-infected your pharmacist may recommend that a second tablet is taken after two weeks.
If anyone takes too much
Children under 2 years old
If any of these apply to you, get advice from a doctor or pharmacist without using Ovex.
Take one tablet per family member.
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If anyone takes more than one Ovex tablet, contact a doctor or your nearest Accident & Emergency department (Casualty) taking this leaflet and pack with you as soon as possible.
Special warnings about this medicine
Ovex is a medicine which is used to treat threadworm (sometimes known as pinworm) infections of the gut. The tablet contains mebendazole, which is one of a group of medicines called 'anthelmintics'.
This medicine is suitable for most adults and children, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Dose
Adults and children aged 2 years and over.
If you are pregnant or breast-feeding
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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-effects, you can help provide more information on the safety of this medicine.
How to store it
this medicine 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 after 'EXPIRY'. The expiry date refers to the last day of that month. There are no special storage conditions. 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.
Contents of the pack and other information
What's in this medicine?
The active ingredient in Ovex is: Mebendazole 100 mg per tablet. Other ingredients are: Microcrystalline cellulose, sodium starch glycollate, talc, maize starch, sodium saccharin, magnesium stearate, cottonseed oil – hydrogenated, orange flavour, colloidal anhydrous silica, sodium laurilsulfate, orange yellow S (E110). . (For further information on some of the ingredients see section 2)
What the medicine looks like
Ovex are pale orange tablets available in packs of 1. Product Licence holder: McNeil Products Limited, 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.
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Manufacturer: Lusomedicamenta Sociedade Técnica, Farmacêutica, S.A., Estrada Consiglieri Pedroso 69-B, Queluz, 2730-055 Barcarena, Portugal. This leaflet was last revised in January 2021. Ovex is a registered trade mark.
7 Further advice regarding threadworms What are threadworms? Threadworms (Enterobius vermicularis) are tiny white parasitic worms that live in the bowel. They are approximately half an inch long and resemble threads of white cotton – hence the name threadworms.
How common are threadworms? Threadworms are extremely common, especially in children. It is estimated that up to 40% of children under ten years in the UK may be affected at any one time. Once a child has threadworms, it is very easy for the rest of the family to get them.
How do they spread? Threadworms spread by producing large numbers of tiny eggs. These eggs are so small that they cannot be seen with the naked eye. When swallowed, the eggs pass into the bowel where they hatch into worms. When mature, the female threadworm lays her eggs at night around the anal area, which causes an "itchy bottom". The resulting irritation can cause intense scratching, which may lead to further infections if the skin becomes sore or broken. Scratching also allows transfer of the eggs to the fingers and nails. Eggs can then be easily transferred to the mouth by finger sucking or nail biting, causing re-infection, and spread to other members of the family by direct contact or via food, towels and bed linen etc. Threadworm eggs are present in house dust; they stick to clothing, carpets, towels and bed linen; they can also be picked up on unwashed vegetables and salads. Because the eggs are so small and so widespread, it is very easy for them to be swallowed.
Lifecycle of threadworms 2 – 6 weeks. 1. Scratching the bottom transfers eggs to fingers and from there back to the mouth or to others either by direct contact or via food, bed linen etc. 2. Eggs swallowed. 3. Female worms migrate to the anal area to lay eggs at night.
Are they harmful? Threadworms do not cause serious damage but they are an irritating problem. Besides the intense itching, which can be distressing and embarrassing for the sufferer, they can also lead to disturbed sleep, tummy aches, irritable crying, loss of appetite or an unusually large appetite. Sometimes, threadworms can be transferred to the vagina and urinary passage. This can result in vaginal irritation and discharge, symptoms of cystitis or bed wetting.
Who gets threadworms? Anyone, although they are more common in children. It does not mean that your family or your home are not clean. Because threadworms are passed on very easily it is a wise precaution to treat everyone in the family at the same time.
How can you tell if someone has threadworms? The most obvious sign of threadworms is intense itching in the anal area, especially at night, although this does not affect everyone. If your children frequently scratch their bottoms, suffer from disturbed sleep or become irritable, it is worth checking their motions and the anal area for tiny white threads. If one member of the family has threadworms, the rest of the family may already have picked up the infection, even if they do not have obvious symptoms. Important note: Threadworms only affect humans, they do not affect pets.
General advice To ensure that you and your family do not infect others or re-infect yourselves, you should also follow the hygiene measures listed below for at least six weeks: ■ Keep nails short. ■ Discourage nail biting or finger sucking. ■ Wear pyjamas or underclothes in bed. ■ In the mornings, wash thoroughly around the bottom. ■ Provide a towel for the exclusive use of each member of the household. ■ Change clothes regularly. ■ Regularly wash and iron bed linen. ■ Thoroughly wash hands and nails after using the toilet and before each meal.
Do you need to keep your children off school? No. As long as the children are treated and the general hygiene measures outlined above are followed, there is no reason to keep them off school.
How can you stop the problem coming back? Threadworms are easily treated but unless the following precautions are taken the problem may recur: ■ ■
Follow the general advice above. Make sure everyone in the family is treated at the same time.
Frequently asked questions about Ovex
What is the active substance in Ovex?
The active substance in Ovex is mebendazole.
Are there equivalent medicines to Ovex?
Medicines with the same active substance, strength and form include: Ovex Family Pack. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ovex, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ovex without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: mebendazole
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the treatment of gastrointestinal infestations of Enterobius vermicularis (threadworm).
There is no evidence that Ovex is effective in the treatment of cysticercosis.
Official guidelines should be taken into consideration.
4.2. Posology and method of administration
Paediatric population
Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine.
Ovex Suspension should be considered for patients such as young children who are unable to swallow the tablet.
Posology
Adults and children over 2 years:
Take one tablet.
Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine. Care should be taken to avoid re-infection and it is strongly recommended that all members of the family are treated at the same time.
It is highly recommended that a second tablet is taken after two weeks, if re-infection is suspected.
Children under 2 years of age:
This medicine has not been extensively studied in children below the age of 2 years. Currently available data are described in section 4.4, 4.8 and 5.2, but no recommendations on a posology can be made. Because of the lack of sufficient safety data, this medicine should not be used in children below the age of 1 year (see section 4.4, 4.8 and 5.2).
Method of administration
Oral
4.3. Contraindications
Ovex is contra-indicated in pregnancy and in patients who have shown hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
4.4. Special warnings and precautions for use
Ovex is not recommended in the treatment of children aged under 2 years.
If symptoms do not disappear within a few days, consult your doctor.
A case-control study of a single outbreak of Stevens-Johnson syndrome /toxic epidermal necrolysis (SJS/TEN) suggested a possible association with the concomitant use of metronidazole with mebendazole. Although there are no additional data on this potential interaction, concomitant use of mebendazole and metronidazole should be avoided.
Convulsions in children, including in infants below one year of age, have been reported very rarely during post-marketing experience with Ovex (see section 4.8). Ovex tablets has not been extensively studied in children below the age of 2 years. Ovex tablets should only be given to very young children if their worm infestation interferes significantly with their nutritional status and physical development. Therefore, Ovex tablets should be used in children aged 1-2 years only if the potential benefit justifies the potential risk. Because of the lack of sufficient safety data, Ovex tablets should not be used in children below the age of 1 year.
Glomerulonephritis and agranulocytosis have been very rarely reported with dosages substantially above those recommended and with treatment for prolonged periods of time.
Ovex Suspension should be considered for patients such as young children who are unable to swallow the tablet.
Orange Yellow S (E110) may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant treatment with cimetidine may inhibit the metabolism of mebendazole in the liver, resulting in increased plasma concentrations of the drug.
Concomitant use of mebendazole and metronidazole should be avoided (see Section 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy
Since Ovex is contra-indicated in pregnancy patients who think they are or may be pregnant should not take this preparation.
Lactation
Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. Therefore, caution should be exercised when Ovex is administered to breast-feeding women.
Fertility
The effect on human fertility has not been evaluated.
4.7. Effects on ability to drive and use machines
Ovex does not affect mental alertness or driving ability.
4.8. Undesirable effects
Throughout this section adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of mebendazole based on the comprehensive assessment of the available adverse event information. A causal relationship with mebendazole cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
At the recommended dose, Ovex is generally well tolerated. However, patients with high parasitic burdens when treated with Ovex have manifested diarrhoea and abdominal pain.
The safety of mebendazole was evaluated in 6276 subjects who participated in 39 clinical trials for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. In these 39 clinical trials, no adverse drug reactions (ADRs) occurred in ≥ 1% of mebendazole-treated subjects.
ADRs identified from clinical trials and post-marketing experience with mebendazole are included in Table 1. The displayed frequency categories use the following convention:
Very common (≥ 1/10); Common (≥ 1/100 and < 1/10); Uncommon (≥ 1/1000 and < 1/100); Rare (≥ 1/10,000 and < 1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data).
Table 1: Adverse Drug Reactions Reported in Clinical Trials and Post‑Marketing Experience for Mebendazole
System Organ Class
Adverse Drug Reactions
Frequency Category
Common
(≥ 1/100 to < 1/10)
Uncommon
(≥ 1/1,000 to < 1/100)
Rare
(≥ 1/10,000 to < 1/1,000)
Very rare
(< 1/10,000)
Blood and lymphatic system disorders
Neutropenia b
Agranulocytosis a, c
Immune system disorders
Hypersensitivity including anaphylactic reaction and anaphylactoid reaction b
Nervous system disorders
Convulsions b
Dizziness a
Gastrointestinal disorders
Abdominal pain a
Abdominal discomfort a
Diarrhoea a
Flatulence a
Nausea b
Vomiting b
Hepatobiliary disorders
Hepatitis b
Abnormal liver function tests b
Skin and subcutaneous tissue disorders
Rash a
Toxic epidermal necrolysis b
Stevens-Johnson syndrome b
Exanthema b
Angioedema b
Urticaria b
Alopecia b
Renal and urinary disorders
Glomerulonephritis a, c
a ADR frequency data derived from Clinical Trials or Epidemiological Studies
b Adverse reactions reported during post-marketing surveillance
c Observed in patients treated for Echinococcosis
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Agranulocytosis and glomerulonephritis are adverse reactions for Echinococcosis treatment for which the dosage is higher and used for prolonged periods of time compared with other indications; therefore, these are expected symptoms of overdose for non-Echinococcosis indications (see Section 4.8).
Signs and symptoms
In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur.
Treatment
There is no specific antidote. Activated charcoal may be given if considered appropriate.
💬 Ask about this leaflet
Ask anything about Ovex. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.