Procto-Glyvenol Cream 5% tube 30 g

What is Procto-Glyvenol and when is it used?

Procto-Glyvenol, rectal cream is used for the local treatment of external and internal hemorrhoids and to relieve the associated itching and local pain.

Procto-Glyvenol, suppositories (suppositories) are used for the local treatment of internal hemorrhoids and the associated complaints.

Hemorrhoids are nodular expansions of the blood vessels (arteries and veins) in the area of the anal sphincter.

External hemorrhoids are often recognizable as painful lumps that cause annoying symptoms such as pain, burning and itching - especially when sitting.

Internal hemorrhoids can manifest themselves as bright red superficial blood admixtures in the feces and pain during bowel movements.

One of the two active ingredients (tribenoside) leads to a reduction in the permeability and an increase in the elasticity of the finest blood vessels at the site of application. It also has an inhibitory effect on a number of substances that play an important role in inflammation and the development of pain. The other active ingredient (lidocaine), a local pain anesthetic, has a pain and itching relieving effect.

What precautions should be taken?

If you suffer from hemorrhoids, you should avoid spicy foods and choose a diet that promotes loose stools (preferably light, plant-based foods). You should avoid becoming overweight or reduce existing excess weight and pay attention to careful anal hygiene. This allows you to support the effects of Procto-Glyvenol.

When should Procto-Glyvenol not be used?

If you are hypersensitive to any of the active ingredients (tribenoside, lidocaine) or excipients, as well as to other amide-type local anesthetics (e.g. prilocaine, articaine), you must not use Procto-Glyvenol.

When should you be careful when using Procto-Glyvenol?

Before using Procto-Glyvenol, talk to your doctor if you are taking beta-blockers (medicines for high blood pressure) or antiarrhythmics (medicines for irregular heartbeat), or if you have liver disease. Procto-Glyvenol should not be used if you have liver disease.

If there is blood loss or suspicion of blood in the stool, as well as pain in the anus and fever at the same time, or if the symptoms persist for more than 14 days, if the symptoms worsen or if unusual or new symptoms appear, you should consult a doctor. When symptoms first appear, self-treatment should not last longer than 2 weeks. Repeated treatments may only be carried out after a medically confirmed diagnosis. They should not last longer than 2 weeks each. A doctor should be consulted for clarification. If hypersensitivity reactions occur, you must stop treatment immediately and ask a doctor for advice.

The preparation must not be taken.

Be careful not to let the product come into contact with your eyes. If this happens, rinse your eyes thoroughly with tap water and if symptoms persist, see a doctor or pharmacist.

Procto-Glyvenol should not be used in children and adolescents because its effectiveness and safety have not been studied in children and adolescents.

cetyl alcohol

Procto-Glyvenol rectal cream contains cetyl alcohol , which can cause localized skin reactions (e.g. contact dermatitis).

Methyl and propyl 4-hydroxybenzoate (E 218/E 216)

The rectal cream also contains methyl and propyl 4-hydroxybenzoate ; These substances can cause allergic reactions, including late reactions.

Tell your doctor, pharmacist or druggist if you

• suffer from other illnesses
• Have allergies or
• Use other medicines (including those you have bought yourself!)

Can Procto-Glyvenol be used during pregnancy or while breastfeeding?

Procto-Glyvenol should not be used during pregnancy, especially in the first three months, unless prescribed by a doctor.

Procto-Glyvenol must not be used during breastfeeding unless specifically prescribed by a doctor. In this case, breastfeeding should be stopped.

How do you use Procto-Glyvenol?

Unless otherwise prescribed by your doctor:

Adults: For acute symptoms:

Internal hemorrhoids:

Insert 1 suppository (suppository) each morning and evening after a bowel movement, or insert the rectal cream twice a day, each morning and evening, using the screw-on applicator provided.

External hemorrhoids:

Apply the rectal cream morning and evening.

For further treatment after the acute symptoms have subsided: 1 suppository (suppository) or a single application of the rectal cream in the morning or evening are sufficient. Suppositories (suppositories) and rectal cream can be used alternately.

How to use rectal cream:

• Wipe the affected area with a suitable cleaning cloth.
• Dry carefully (with soft tissue) before applying the rectal cream.

For external use (without applicator):

Apply rectal cream around the anus with a clean finger.

For use in the anal canal (with applicator):

• After removing the tube cap, screw the included applicator onto the tube.
• Remove protective cap from applicator.
• Insert the applicator carefully and not too deeply into the anus and press carefully onto the tube.
• After each use, clean the outside of the applicator with a damp cloth or a damp cotton ball and put the protective cap back on.

After use, wash hands thoroughly with soap and water.

Application of the suppositories (= suppositories):

• Wash hands thoroughly before and after use.
• Separate 1 suppository (suppository) from the foil strip and remove it from the foil.
• Before using the suppository (suppository), clean the affected area with a soft tissue or cloth and dry gently.
• 1 Carefully insert the suppository (suppository) into the anus so that it does not protrude.
• Do not use aids such as petroleum jelly or oils to make insertion easier.

Duration of use: Use Procto-Glyvenol until the symptoms subside. If symptoms persist for more than 2 weeks or worsen, you should see a doctor.

Do not exceed the recommended dosage. Make sure that the cream or suppositories (suppositories) do not come into contact with the eyes.

Do not take.

There is no experience with overdose. If you have taken Procto-Glyvenol or have exceeded the recommended dosage, you should consult a doctor.

Children and young people

Procto-Glyvenol should not be used in children and adolescents because its effectiveness and safety have not been studied in children and adolescents.

Stick to the dosage stated in the package leaflet or prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Procto-Glyvenol have?

Like all medicines, Procto-Glyvenol can cause side effects, although not everyone gets them.

The following side effects occur very rarely (affects less than 1 in 10,000 people):

Severe allergic reactions (anaphylactic reactions) may occur after using Procto-Glyvenol.

Stop treatment with Procto-Glyvenol and see a doctor immediately if one or more of the following symptoms occur, which may be signs of a serious allergic reaction:

• Wheezing, shortness of breath, chest tightness (asthma)
• Difficulty swallowing
• Swelling of the face, lips, tongue and/or throat area
• severe itching with a red rash and/or bumps on the skin
• irregular heartbeat.

The following side effects occur rarely ( affects 1 to 10 in 10,000 people):

Skin reactions such as burning, itching or redness. These reactions may occur at the site where the product was applied or spread from there.

If you notice any side effects, contact your doctor, pharmacist or druggist. This applies in particular to side effects that are not stated in this leaflet.

What should also be noted?

durability

The medicine may only be used until the date marked “EXP” on the pack.

Use-by period after opening

Procto-Glyvenol rectal cream:

When used with an applicator: Shelf life is 14 days after first opening.

Storage instructions

Keep out of the reach of children.

Store at room temperature (15-25°C) and in the original packaging.

More information

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What is contained in Procto-Glyvenol?

Active ingredients

Procto-Glyvenol rectal cream

1 g rectal cream contains: 50 mg tribenoside and 20 mg anhydrous lidocaine hydrochloride (as lidocaine hydrochloride monohydrate equivalent to 17 mg lidocaine).

Procto-Glyvenol suppositories (suppositories)

1 suppository (suppository) contains: 400 mg tribenoside and 40 mg lidocaine

Excipients

Procto-Glyvenol rectal cream

Cetyl alcohol, isopropyl palmitate, macrogol cetostearyl ether, thick paraffin, sorbitan monostearate, sorbitol solution (non-crystallizing), stearic acid, methyl and propyl 4-hydroxybenzoate (E 218, E 216), and purified water. The cream is white.

Procto-Glyvenol suppository (suppositories)

Hard fat. The suppositories are yellowish-white and torpedo-shaped.

Approval number

36800, 36801 (Swissmedic)

Where can you get Procto-Glyvenol? Which packs are available?

In pharmacies and drugstores, without medical prescription.

• Procto-Glyvenol rectal cream: 30 g.
• Procto-Glyvenol suppositories: 10 pieces.

Authorization holder

Haleon Schweiz AG, Risch.