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SALOFALK 1 g SUPPOSITORIES

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About the medicine

How to use SALOFALK 1 g SUPPOSITORIES

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Salofalk1g Suppositories

Mesalazine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

  1. What is Salofalk 1g Suppositories and what is it used for
  2. What you need to know before you use Salofalk 1g Suppositories
  3. How to use Salofalk 1g Suppositories
  4. Possible side effects
  5. Storage of Salofalk 1g Suppositories

Contents of the pack and further information

1. What is Salofalk 1g Suppositories and what is it used for

Salofalk 1g Suppositories contains the active substance mesalazine, an anti-inflammatory that is used to treat inflammatory bowel diseases.

Salofalk 1g Suppositories is used for:

treatment of acute episodes of mild to moderate ulcerative colitis or proctitis, limited to the rectum.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use Salofalk 1g Suppositories

Do not useSalofalk1g Suppositories

  • if you are allergic to salicylic acid, salicylates such as acetylsalicylic acid (e.g. Aspirin) or any of the other components of this medicine (listed in section 6).
  • if you have severe liver or kidney disorders.

Warnings and precautions

Consult your doctor before starting to use Salofalk 1g Suppositories

  • if you have a history of lung disease, particularly if you suffer from bronchial asthma
  • if you are allergic to medicines containing sulfasalazine, a substance related to mesalazine
  • if you have liverproblems
  • if you have kidneyproblems
  • If you have ever suffered from a severe skin rash, skin peeling, blisters, or ulcers in the mouth after using mesalazine.

Mesalazine may cause a discoloration of the urine to a reddish-brown color after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Additional precautions

During treatment, your doctor may want to keep you under medical supervision, and you may need to have regular blood and urine tests.

Kidney stones can occur with the use of mesalazine. The symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink a sufficient amount of liquid during treatment with mesalazine.

Severe skin reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (NET), have been observed with mesalazine treatment. Stop taking mesalazine and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Using Salofalk 1g Suppositories with other medicines

Tell your doctor if you are using or taking any of the following medicines, as the effects of these medicines may be altered (interactions):

  • Azathioprine, 6-mercaptopurine or thioguanine(medicines for treating immune system disorders)
  • Certain agents that inhibit blood coagulation(medicines for thrombosis or to thin the blood, such as warfarin)

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It may be correct to use Salofalk 1g Suppositories and your doctor will decide what is appropriate for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should use Salofalk 1g Suppositories during pregnancy only if your doctor has told you to.

Similarly, you should only use Salofalk 1g Suppositories during breastfeeding if your doctor has told you to. This medicine may pass into breast milk.

Driving and using machines

The influence of Salofalk 1g Suppositories on the ability to drive or use machines is negligible.

Important information about some of the ingredients of Salofalk 1g Suppositories

It is unlikely that the other component of Salofalk 1g Suppositories will cause side effects (see section 6. Further information).

3. How to use Salofalk 1g Suppositories

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again.

Method of administration

This medicine can only be used rectally, so it must be inserted through the anus. It must not be swallowed.

Posology

Adults and the elderly

The recommended dose is 1 suppository once a day, at bedtime.

Use in children

There is limited experience and documentation of the effect in children.

Duration of treatment

Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. Your doctor will decide how long you need to continue treatment with this medicine, depending on the progression of your disease.

In order to achieve the desired therapeutic effects, you should use Salofalk 1g Suppositories regularly and uniformly, as indicated.

If you think that Salofalk 1g Suppositories is too strong or too weak, talk to your doctor.

If you use more Salofalk 1g Suppositories than you should

Contact your doctor if you have any doubts, so that he or she can decide what to do.

If you use too much Salofalk 1g Suppositories at one time, just apply the next dose as prescribed. Do not use a smaller dose.

If you forget to use Salofalk 1g Suppositories

If you forget to use this medicine, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Use the next dose at the usual time. Do not use a double dose to make up for forgotten doses.

If you stop using Salofalk 1g Suppositories

Do not stop using this medicine until you have talked to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following symptoms after using this medicine, you should contact your doctor and stop using Salofalk 1g Suppositories immediately:

  • General allergic reactionssuch as skin rashes, fever, joint pain, and/or breathing difficulties or a general inflammation of your large intestine (which causes severe diarrhea and abdominal pain). These reactions are very rare.
  • A marked decrease in your general health, especially if accompanied by fever and/or sore throat and mouth. These symptoms can be due, very rarely, to a decrease in the number of white blood cells in the blood, which can make you more prone to developing a serious infection (agranulocytosis). Other blood cells (such as platelets or red blood cells, which cause aplastic anemia or thrombocytopenia) may also be affected and cause symptoms that can include unexplained bleeding, bruising, or purple spots under the skin, anemia (feeling tired, weak, and pale, especially in the lips and nails). A blood test can confirm if your symptoms are due to an effect of this medicine on your blood. These reactions are very rare.
    • Severe skin rashes with reddish patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and enlargement of the lymph nodes. These can be preceded by fever or flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
    • Breathing difficulties, chest pain, or irregular heartbeats, or swollen limbs that may indicate cardiac hypersensitivity reactions. These reactions are rare.
    • Kidney problems(can occur very rarely), such as a change in the color or amount of urine produced and swollen limbs or sudden pain in the side (caused by a kidney stone) (occur in an unknown number of patients (frequency not known)).

The following side effects have also been reported by patients using mesalazine:

Common side effects(may affect up to 1 in 10 patients)

  • Rash, itching

Uncommon side effects(may affect up to 1 in 100 patients)

  • Abdominal pain, diarrhea, flatulence (gas), nausea, and vomiting, constipation
  • Headache, dizziness
  • Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

Rare side effects(may affect up to 1 in 1,000 patients)

  • Severe abdominal pain due to acute inflammation of the pancreas
  • Shortness of breath, cough, wheezing, lung shadow on X-ray due to allergy and/or inflammatory condition of the lungs
  • Muscle and joint pain
  • Jaundice or abdominal pain due to liver and bile duct disorders
  • Hair loss and development of baldness
  • Numbness and tingling in hands and feet (peripheral neuropathy)
  • Reversible decrease in semen production

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Vigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Salofalk 1g Suppositories

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 blister pack of the suppositories and on the carton. The expiry date is the last day of the month stated.

Store at a temperature not above 30°C. Keep in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Salofalk 1g Suppositories

The active substance of Salofalk 1g Suppositories is mesalazine, and one suppository of Salofalk 1g Suppositories contains 1g of mesalazine.

The other component is:

hard fat.

Appearance of the product and pack contents

Salofalk 1g Suppositories are torpedo-shaped suppositories of ivory color.

Salofalk 1g Suppositories is available in packs of 10, 12, 15, 20, 30, 60, and 90 suppositories.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Dr. Falk Pharma GmbH

Leinenweberstr. 5

79108 Freiburg

Germany

Tel +49 (0) 761 / 1514-0

Fax +49(0) 761 / 1514-321

E-mail: [email protected]

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

Dr. Falk Pharma España

Camino de la Zarzuela, 19

28023 Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany, Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, United Kingdom, Greece, Hungary, Ireland, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, and Spain: Salofalk

Belgium and Luxembourg: Colitofalk.

France: Osperzo

Italy: Cletrovaproct

Date of last revision of this leaflet:August 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

Online doctors for SALOFALK 1 g SUPPOSITORIES

Discuss questions about SALOFALK 1 g SUPPOSITORIES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (5)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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€80
5.0 (181)
Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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€50
0.0 (0)
Doctor

Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

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€55
0.0 (0)
Doctor

Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

  •  Neuroimaging
  •  Musculoskeletal system (MSK)
  •  Angiography
  •  Abdomen and pelvis
  •  Soft tissues

Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

Camera Book a video appointment
€80

Frequently Asked Questions

Is a prescription required for SALOFALK 1 g SUPPOSITORIES?
SALOFALK 1 g SUPPOSITORIES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in SALOFALK 1 g SUPPOSITORIES?
The active ingredient in SALOFALK 1 g SUPPOSITORIES is mesalazine. This information helps identify medicines with the same composition but different brand names.
How much does SALOFALK 1 g SUPPOSITORIES cost in pharmacies?
The average pharmacy price for SALOFALK 1 g SUPPOSITORIES is around 45.13 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures SALOFALK 1 g SUPPOSITORIES?
SALOFALK 1 g SUPPOSITORIES is manufactured by Dr. Falk Pharma Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SALOFALK 1 g SUPPOSITORIES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether SALOFALK 1 g SUPPOSITORIES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to SALOFALK 1 g SUPPOSITORIES?
Other medicines with the same active substance (mesalazine) include ASACOL 1 G SUPPOSITORIES, ASACOL 1600 mg GASTRO-RESISTANT TABLETS, ASACOL 400 mg GASTRO-RESISTANT TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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