Rozex 0.75% gel

What is Rozex?

Rozex is a prescription-only medicine applied to the skin to treat rosacea. It contains metronidazole 0.75% w/w, which is 7.5 mg of metronidazole in each gram, and is made in two forms: Rozex 0.75% w/w Gel, a colourless to pale yellow gel that may turn slightly brown over time, and Rozex 0.75% w/w Cream. Both are made by Galderma (U.K.) Limited (gel PL 10590/0016, cream PL 10590/0028).

In the UK, Rozex gel and Rozex cream are licensed for the same use: the treatment of the inflammatory papules (red bumps), pustules (pus-filled spots) and erythema (redness) of rosacea. Rosacea is a long-term inflammatory skin condition that mainly affects the face. Rozex is not licensed for acne or for any other skin condition.

How does Rozex work?

Metronidazole is an antiprotozoal and antibacterial agent that is active against a wide range of micro-organisms. The SmPC states that the way it works in rosacea is not known, but that the available evidence suggests the effect may be antibacterial and/or anti-inflammatory. The patient leaflet describes it as helping to control infection and inflammation in skin problems such as rosacea.

Very little metronidazole is absorbed through the skin. In a study of Rozex gel applied to the face, the highest blood levels were around 100 times lower than after a single 250 mg metronidazole tablet, and in most people at most time points the level was below the limit the assay could detect. That is why the side effects seen with metronidazole taken by mouth have not been reported with Rozex.

Rozex gel or cream?

The gel and the cream contain the same strength of metronidazole, have the same licensed use and are applied in the same way. They differ in their base:

• Rozex gel is a water-based gel containing carbomer, disodium edetate, methyl and propyl parahydroxybenzoate (E218 and E216), propylene glycol (30 mg per gram), sodium hydroxide and purified water.
• Rozex cream is an emulsion containing emulsifying wax (cetostearyl alcohol and polysorbate 60), benzyl alcohol (E1519, 22 mg per gram), isopropyl palmitate, glycerol, sorbitol, lactic acid and/or sodium hydroxide and purified water.

Which base suits you is a matter of skin type and preference. Tell the prescriber if you have reacted to any of these ingredients before, or if you have a preference, so that the form supplied is the right one for you. The form you receive is confirmed on your prescription and the pack.

How to use Rozex

Always use Rozex exactly as your prescriber has told you, and read the patient information leaflet in your pack.

• Rozex is for use on the skin only. Do not swallow it; if you do so accidentally, seek medical advice.
• First wash the affected areas of skin with a mild cleanser and dry them.
• Apply a thin layer of the gel or cream to all the affected areas twice a day, in the morning and in the evening, and rub it in well.
• Be careful not to get Rozex in your eyes. If you do, rinse thoroughly with large amounts of warm water or an eye wash.
• Replace the cap and wash your hands after each application.
• You may use non-comedogenic, non-astringent cosmetics after applying Rozex.
• If you forget an application, do not worry; when you remember, start using it again in the same way as before.

Rosacea can respond slowly, so it is important to keep using Rozex until your prescriber tells you to stop. Store the gel below 25°C and do not freeze it; store the cream below 25°C and do not refrigerate it.

How long is Rozex used for?

According to the SmPC, the average period of treatment is three to four months, and this recommended duration should not be exceeded. If a clear benefit has been shown, the prescriber may consider continuing treatment for a further three to four months, depending on the severity of the rosacea; in clinical studies, topical metronidazole has been continued for up to 2 years. If there is no clear improvement, the SmPC advises that treatment should be stopped. Unnecessary and prolonged use should be avoided.

Possible side effects of Rozex

Like all medicines, Rozex can cause side effects, although not everybody gets them. The SmPC describes the reactions reported with Rozex as local and mild:

• Common (may affect up to 1 in 10 people): dry skin, redness (erythema), itching (pruritus), skin discomfort such as burning, pain or stinging, skin irritation, and worsening of rosacea.
• Uncommon (may affect up to 1 in 100 people): numbness (hypoaesthesia) and tingling (paraesthesia) in the fingers or toes, a metallic taste (dysgeusia), and feeling sick (nausea).
• Not known (frequency cannot be estimated): contact dermatitis, swelling of the face, and peeling skin (exfoliation).

Watery eyes have been reported when Rozex is applied too close to the eyes. If skin irritation occurs, use Rozex a little less often or stop using it until the irritation settles, and seek advice from your pharmacist or prescriber if necessary. Suspected side effects can be reported through the MHRA Yellow Card scheme.

Precautions when using Rozex

• Avoid contact with the eyes and with mucous membranes (the lining of the nose and mouth).
• Avoid strong sunlight, including sunbathing, and ultraviolet light such as solariums and sun-lamps while using Rozex: UV light turns metronidazole into an inactive form, so its effect is significantly reduced.
• Metronidazole should be used with care if you have, or have had, a blood disorder (blood dyscrasia). The leaflet says not to use Rozex in that case unless your doctor says you can.
• Anticoagulants: metronidazole taken by mouth can increase the effect of warfarin and other coumarin anticoagulants. The effect of topical metronidazole is not known, but very rare changes in INR have been reported when Rozex was used alongside coumarin anticoagulants. Tell the prescriber if you take a medicine to thin the blood.
• Alcohol: metronidazole taken by mouth can react with alcohol (a disulfiram-like reaction). This is unlikely with Rozex because very little is absorbed, but the leaflet advises not drinking alcohol while you are using it.
• Pregnancy and breastfeeding: there is no experience of Rozex in pregnancy, and the SmPC says it should be used in pregnancy only if clearly needed. After oral use metronidazole passes into breast milk; levels after topical use are much lower, but a decision is made with the prescriber about whether to stop breastfeeding or not to use Rozex. Tell the prescriber if you are pregnant, planning a pregnancy or breastfeeding.
• Children: Rozex is not recommended for children because safety and efficacy have not been established.
• Rozex has no influence on the ability to drive or use machines.
• Excipients: the gel contains methyl and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed), and propylene glycol, which may cause skin irritation. The cream contains cetostearyl alcohol, which may cause local skin reactions such as contact dermatitis, benzyl alcohol, which may cause allergic reactions and mild local irritation, and polysorbate 60, which can cause allergic reactions.

Who should not use Rozex

Do not use Rozex if you are allergic (hypersensitive) to metronidazole or to any of the other ingredients of the form you have been given; an allergic reaction may include a rash or itching.

Rozex must not be used by anyone with Cockayne syndrome, a rare inherited condition. Cases of severe liver toxicity and acute liver failure, including some with a fatal outcome and very rapid onset, have been reported in people with Cockayne syndrome treated with metronidazole products taken by mouth or injection.

If you have a blood disorder, take an anticoagulant, are pregnant or breastfeeding, or have reacted to a skin product before, tell the prescriber during your consultation so that they can decide whether Rozex is suitable for you.

Rozex and other rosacea treatments

Rozex is one of several prescription treatments licensed for the papules and pustules of rosacea, and a prescriber chooses between them on your diagnosis, the pattern of your rosacea, other medicines you take and how your skin has reacted before:

• Finacea is a 15% azelaic acid gel licensed for papulopustular rosacea, applied twice a day.
• Soolantra is a 10 mg/g ivermectin cream licensed for the inflammatory lesions of papulopustular rosacea in adults, applied once a day to the face.
• Rozex is the metronidazole option, in a gel or a cream, applied twice a day, with the advice to avoid strong sunlight and UV light during use.

Do not combine rosacea treatments on your own initiative. Whether a combination is appropriate is a prescribing decision.

Is Rozex available on the NHS?

Yes. Rozex gel and Rozex cream can be prescribed on the NHS by a GP or a dermatologist where they consider it appropriate, and the usual NHS prescription charge or exemption applies. MediHealth Direct supplies Rozex on a private prescription after an online consultation, so the price shown on this page is the private cost of the medicine, not an NHS charge.

Patient information leaflets

Read the leaflet for the form you have been given before you use Rozex and keep it for reference: Rozex 0.75% Gel patient information leaflet or Rozex 0.75% Cream patient information leaflet (medicines.org.uk). The prescriber information this page is based on is the Rozex Gel Summary of Product Characteristics and the Rozex Cream Summary of Product Characteristics.

Getting Rozex from MediHealth Direct

Rozex is a prescription-only medicine, so it can only be supplied against a prescription. To request it, complete an online consultation about your skin and your medical history. A UK-registered prescriber reviews your answers and decides whether Rozex is appropriate for you; if it is, a private prescription is issued and the medicine is dispensed by our GPhC-registered pharmacy. If a different treatment would suit you better, the prescriber will say so.

FAQs about Rozex

What is Rozex used for?

Rozex is licensed in the UK for the treatment of the inflammatory papules (red bumps), pustules (spots) and erythema (redness) of rosacea, a long-term inflammatory skin condition of the face. It contains metronidazole 0.75% and is applied to the affected skin twice a day. It is not licensed for acne or for any other skin condition, and it is not recommended for children.

Is Rozex a gel or a cream?

Both. Rozex is made as a 0.75% gel and a 0.75% cream, which contain the same strength of metronidazole, are licensed for the same use and are applied in the same way, twice a day. They differ in their base ingredients: the gel is water-based with parahydroxybenzoate preservatives and propylene glycol, while the cream is an emulsion with cetostearyl alcohol and benzyl alcohol. The form you receive is confirmed on your prescription and pack.

How long does Rozex take to work?

Rosacea may respond slowly, so the leaflet advises continuing Rozex until your prescriber tells you to stop. The SmPC gives an average treatment period of three to four months, and if there is no clear improvement the treatment should be stopped rather than continued indefinitely. If you are unsure whether Rozex is working for you, ask your prescriber or pharmacist rather than stopping on your own.

Can I drink alcohol while using Rozex?

Metronidazole taken by mouth can react with alcohol (a disulfiram-like reaction), and the SmPC notes that such reactions have been reported in a small number of patients taking metronidazole and alcohol together. The reaction is unlikely with Rozex because very little metronidazole is absorbed through the skin, but the patient leaflet still advises not to drink alcohol while you are using Rozex gel or cream.

Can I go in the sun while using Rozex?

The leaflet advises not to go out in strong sunlight, including sunbathing, and to avoid ultraviolet light such as solariums and sun-lamps while using Rozex. UV light turns metronidazole into an inactive form, so its effect is significantly reduced. No phototoxic reactions were reported in clinical trials, but the advice to avoid or minimise sun exposure of treated skin also follows from animal studies described in the SmPC.

Is Rozex an antibiotic?

Metronidazole, the active ingredient of Rozex, is an antiprotozoal and antibacterial agent, so it belongs to the antibiotic family. How it works in rosacea is not known; the SmPC says the effect may be antibacterial and/or anti-inflammatory. Because so little is absorbed through the skin, the side effects of metronidazole tablets have not been reported with Rozex, but the leaflet still advises avoiding alcohol and telling your prescriber about anticoagulants.

Can I use Rozex during pregnancy or while breastfeeding?

There is no experience of Rozex in pregnancy, and the SmPC says it should be used in pregnancy only if clearly needed. Metronidazole passes into breast milk after oral use; levels after topical use are much lower, but the leaflet says Rozex may not be advisable while breastfeeding unless your doctor considers it essential. Tell the prescriber during your consultation if you are pregnant, planning a pregnancy or breastfeeding.

What should I do if Rozex irritates my skin?

Dry skin, redness, itching, burning or stinging and skin irritation are common side effects of Rozex, and are described in the SmPC as local and mild. If irritation occurs, the leaflet advises using Rozex a little less often or stopping until the irritation settles, and seeking advice from your doctor or pharmacist if necessary. Stop and seek advice if you think you are having an allergic reaction, such as a rash or itching that does not settle.

Does Rozex interact with warfarin?

Metronidazole taken by mouth can increase the effect of warfarin and other coumarin anticoagulants, prolonging the prothrombin time. The effect of topical metronidazole on prothrombin is not known, but very rare changes in INR have been reported when Rozex was used alongside coumarin anticoagulants. If you take warfarin or another medicine to thin the blood, tell the prescriber during your consultation and contact your doctor for advice before using Rozex.