Prospecto: information for the user

Synalar rectal simple 0.1 mg/g rectal cream

Fluocinolone acetonide

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What Synalar rectal simple is and for what it is used

2.What you need to know before starting to use Synalar rectal simple

3.How to use Synalar rectal simple

4.Possible adverse effects

5.Storage of Synalar rectal simple

6.Contents of the package and additional information

The active ingredient is fluocinolone acetonide. Synalar rectal simple belongs to a group of medications known as topical agents (external use) for the treatment of hemorrhoids, corticosteroids, which act by reducing anal and rectal inflammation and anal itching associated with hemorrhoids.

Synalar rectal simple is indicated for the local symptomatic treatment of anal and rectal inflammation and anal itching (pruritus) associated with hemorrhoids in adults.

Do not use Synalar rectal simple:

• if you are allergic to fluocinolone acetonide or any of the other ingredients of this medication (listed in section 6).
• if you have bleeding hemorrhoids.
• if you have an infection in the area to be treated by bacteria, viruses (e.g., herpes) or fungi.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Synalar rectal simple.

• Older adults and severely debilitated patients in an acute phase should exercise special caution, as they may be more sensitive to the toxic effects of this medication.
• Prolonged use, occlusive treatment (with materials that do not allow air circulation in the area) or with diapers, of topical corticosteroids may cause skin, mucous membrane, and subcutaneous tissue atrophy.
• Prolonged use or in large quantities may cause systemic effects (those that occur when the medication is absorbed and reaches the blood).
• If you present an infection in the treated area, it should be treated separately. If no rapid improvement is seen, discontinue treatment with Synalar rectal simple until the infection has been controlled. The use of corticosteroids may potentiate skin infections.
• Patients with severely damaged mucosa and/or infection in the application area should exercise special caution.
• If the product causes irritation, discontinue its application.
• Avoid contact with the eyes or around them and mucous membranes.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Use in athletes

It is warned to athletes that this medication contains a component, fluocinolone, which may produce a positive result in doping control tests.

Children and adolescents

The safety and efficacy of Synalar rectal simple have not been established in children and adolescents.

No data are available.

Other medications and Synalar rectal simple

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

You should not apply other preparations to the treated area in conjunction with Synalar rectal simple.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use Synalar rectal simple for a prolonged period if you are pregnant. Its use should be reserved for cases where the therapeutic benefit is greater than the possible risk.

Similarly, caution is advised if this medication needs to be used while breastfeeding.

Driving and operating machines

Synalar rectal simple does not affect the ability to drive and/or operate machines.

Synalar rectal simple contains cetomacrogol, cetearyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and propylene glycol (E1520)

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetomacrogol and cetearyl alcohol.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

This medication contains 150 mg of propylene glycol in each gram of cream.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

Apply the cream 1 or 2 times a day, after evacuating.

Before applying Synalar rectal simple, the affected area must be cleaned carefully, dried, and a quantity of cream equivalent to 2 cm applied to the anal and/or rectal area using a clean gauze.

If you have internal hemorrhoids and the cream needs to be applied inside the rectum, screw the cannula that comes with the package into the tube and insert the tip into the anus. Then, apply a small amount of cream while exerting gentle pressure on the tube.

If you use more Synalar rectal simple than you should

Using too much Synalar rectal simple could cause adrenal suppression (a disorder that causes an alteration in the normal production of hormones secreted by glands located near the kidneys), with symptoms such as obesity in the trunk, rounded face, accumulation of fat in the cervical area, delayed healing, etc.); other symptoms may include cataracts. In this case, treatment should be interrupted and the doctor should monitor your adrenal hormonal axis function.

An accidental ingestion may causeaccelerated heart rate(tachycardia)and occasional elevations in blood pressure, which resolve without the need for medical treatment.

In case ofoverdose or accidental ingestion,consult your doctor or pharmacist immediately, or callthe Toxicological Information Service, phone 91 562 04 20, or visit a medical center indicating the medication and the amount used.

If you forgot to use Synalar rectal simple

Do not use a double dose to compensate for the missed doses.

If you forget to apply Synalar rectal simple at the scheduled time, do it as soon as you remember and then continue as before.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The possible adverse effects are listed according to the following categories:

-Rare: may affect up to 1 in 1,000 people

-Very Rare: may affect up to 1 in 10,000 people

-Unknown Frequency: cannot be estimated from available data

Rare Adverse Effects

- Skin atrophy with thinning of the epidermis (often irreversible)

- Dilatation of small blood vessels on the surface of the skin (telangiectasia)

- Presence of red patches and spots on the skin (purpura)

- Striae on the skin

- Acne-like eruptions

- Perioral dermatitis (small red papules around the mouth)

- Loss of skin pigmentation (depigmentation)

- Skin eruptions (dermatitis and eczema, including contact dermatitis)

- Burning sensation

- Bounce-back effect

Very Rare Adverse Effects

- Adrenal suppression, which causes an alteration in the normal production of hormones produced by glands located near the kidneys (see in section 3 "If you use more Synalar rectal simple than you should").

Adverse Effects of Unknown Frequency

- Hypersensitivity (allergic reactions)

- Pruritus (itching)

- Dry skin

- Skin maceration

- Secondary infection

- Blurred vision

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medication out of the sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Synalar rectal simple

• The active ingredient is fluocinolone acetonide. Each gram of cream contains 0.1 mg of fluocinolone acetonide (0.01%).
• The other components are: cetyl alcohol, stearyl alcohol, sorbitan stearate, polisorbate 60 (E435), liquid paraffin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), anhydrous citric acid (E330), and purified water.

Appearance of the product and content of the packaging

Synalar rectal simple is a rectal cream, white in color. It is presented in tubes of 30 and 60 grams. The packaging comes with a cannula for intrarectal application when required.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Karo Pharma AB

Box 16184

103 24 Stockholm

Sweden

Responsible for manufacturing

Temmler Italia S.R.L.

Via delle Industrie, 2

280061 Carugate, Milan

Italy

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid

Spain

Last review date of this leaflet: December 2018.

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/. http://www.aemps.gob.es/