Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Histamine dihydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Soluprick is a solution for skin prick testing. Soluprick Positive and Negative Control are for diagnostic use only. They are used as a reference with other skin prick tests to determine which substances cause your allergic reaction. The Histamine Dihydrochloride in the Soluprick Positive Control will produce a hard raised wheal, which may be surrounded by a red area and this is called a positive response. This response is compared with the responses from substances that you might be allergic to. Soluprick Negative Control will usually not cause any reaction, and is used to ensure that positive responses are not caused by the prick of the lancet.
e Soluprick Do not use Soluprick Positive and Negative Control
Some medicines can affect the results of the skin prick test, therefore: Tell your doctor or healthcare professional before the skin prick test is carried out if you are taking any of the following medicines:
Soluprick Prick testing may be performed in children over the age of one if the child is able to tolerate the procedure, but in general should not be performed before of the age of 4. Your doctor or health professional will carry out the skin prick test for you. The procedure is as follows:
Like all medicines, Soluprick can cause side effects, although not everybody gets them. In some cases you may experience slight pain at the skin prick test site (frequency not known).
Soluprick Positive Control will cause the expected local effects associated with histamine. The Soluprick Positive Control will produce a hard raised wheal, which may be surrounded by a red area and local itching after the test. Reporting of side effects If you get 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 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.
Soluprick Keep this medicine out of the sight and reach of children. The clinic/hospital will store the skin prick test solution. Store in a refrigerator (2°C – 8°C). Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Soluprick should be used within six months after first opening. 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.
What Soluprick contains The active substance in Soluprick Positive Control is Histamine Dihydrochloride. There is no active substance in Soluprick Negative Control. The other ingredients are phenol, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, glycerol, water for injection, sodium hydroxide and hydrochloric acid. What Soluprick looks like and contents of the pack Soluprick is supplied in a glass vial containing 2 ml clear solution. The vial is closed with a rubber stopper and a screw cap. Marketing Authorisation Holder ALK Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm, Denmark Manufacturer
ALK-Abelló S.A., Miguel Fleta 19, E-28037 Madrid, Spain Distributor ALK-Abelló Ltd., 1 Manor Park, Manor Farm Road, Reading, Berkshire, RG2 0NA, United Kingdom, Tel: 0118 903 7940 This leaflet was last revised in 07/2025
The active substance in Soluprick Controls is histamine dihydrochloride.
This leaflet reproduces the patient information leaflet approved for Soluprick Controls, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
This medicinal product is for diagnostic use only.
Positive and negative control of skin-prick tests for diagnosis of specific IgE-mediated allergy.
A skin-prick test (SPT) is performed by administering a drop of the product on the surface of the skin. The skin is penetrated using a lancet. The skin-prick test may be performed on the volar side of the forearm or on the back.
Soluprick Positive Control (Histamine dihydrochloride 10 mg/ml) is applied as reference to evaluate the general reactivity of the skin-prick test, and Soluprick Negative Control is applied to evaluate unspecific reactions.
Skin-prick testing should be performed by experienced personnel only.
Paediatric population
Prick testing in children is already possible after the first year of life depending on the child's constitution, but in general should not be performed before the age of 4.
Instructions for use
• The skin-prick test is normally performed on the volar side of the forearm. Alternatively the test may be performed on the patient's back.
• The skin must be dry and clean. It is recommended to wash the test area with an alcoholic solution.
• Each test solution and the positive and the negative control are applied in droplets on the skin placed at least 1.5 cm. apart. The forearm should be at rest. Apply the positive and the negative control after the active tests.
• The superficial layer of the skin is pierced through the droplet perpendicular to the skin using a 1 mm tip standardized lancet. A new lancet must be used for each allergen.
• Apply a slight, constant pressure for approximately 1 second. Draw the lancet straight back.
• Surplus allergen extract is removed with a tissue. It is important to avoid contamination between the allergens.
• The reactions are read after 15 minutes.
• A positive reaction is a wheal with or without erythema.
• The result may be transferred to a test form as follows: Mark the contour of the actual wheal. Transfer the result to the test form with the adhesive side of transparent tape, where after the reaction can be read on graph paper.
• A wheal with a diameter of at least 3 mm is considered to be a positive reaction.
• For the Soluprick Negative Control no reaction is expected. In case of a positive reaction with the Soluprick Negative Control the skin-prick test in general must be regarded as not reliable.
Hypersensitivity to any of the excipients listed in section 6.1.
Soluprick Positive Control
Skin disorders or lesions in the area used for testing
Skin prick testing with Soluprick Positive Control should only be performed on healthy skin without lesions.
If the patient has any skin disorders in the area for testing such as dermographism, atopic dermatitis or eczema, it may influence the interpretation of the test outcome. If applicable, the back may be used or the skin prick test postponed until the disorder is stabilised.
General condition of the patient
Diseases seriously affecting the general condition of the patient may influence the test outcome. In these cases, skin prick testing with Soluprick Positive Control should be postponed until the patient is stabilised.
Special populations
Decreased wheal size may be observed in infants and the elderly.
Soluprick Negative Control
Skin disorders or lesions in the area used for testing
Skin prick testing with Soluprick Negative Control should only be performed on healthy skin without lesions.
If the patient has any skin disorders in the area for testing such as dermographism, atopic dermatitis or eczema, it may influence the interpretation of the test outcome. If applicable, the back may be used or the skin prick test postponed until the disorder is stabilised.
General condition of the patient
Diseases seriously affecting the general condition of the patient may influence the test outcome. In these cases, skin prick testing with Soluprick Negative Control should be postponed until the patient is stabilized.
Soluprick Positive Control
No interaction studies have been performed for Soluprick Positive Control.
Concomitant treatment with other medications may suppress the immediate reaction to skin prick testing with Soluprick Positive Control and could lead to a false-negative result.
The following is recommended:
• Treatment with short-acting antihistamines should be stopped at least 3 days before skin prick test is performed and treatment with longer-acting antihistamines about 1 week prior to testing.
• Topical application of highly effective glucocorticoids in the area of testing can suppress the reaction to the skin prick test for up to 3 weeks (depending on the strength of the preparation).
• Systemically administered corticosteroids in low doses (up to 10 mg prednisolone equivalents per day) need not be discontinued prior to skin prick testing. Long-term use of higher doses may influence the reaction to the skin prick test for up to 3 weeks after discontinuation. For short-term use of corticosteroids (>10 mg prednisolone equivalents per day), skin testing should not be performed any earlier than 1 week after discontinuation.
Other medications may influence the skin prick test result through an antihistamine-like effect (such as tricyclic antidepressants). Caution should be taken when interpreting the skin prick test results and elimination-time as stated in the relevant product information should be considered.
Soluprick Negative Control
Not applicable.
Pregnancy:
There are no or limited amount of data from the use of Soluprick Positive and Negative Control in pregnant women. Soluprick Positive and Negative Control should not be used in pregnant women unless the benefits are considered by the treating physician to outweigh the risks.
Breastfeeding:
No clinical data are available for the use of Soluprick Positive and Negative Control during breastfeeding. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to Soluprick Positive and Negative Control is negligible.
Fertility:
There is no clinical data with respect to fertility for the use of Soluprick Positive and Negative Control.
Soluprick Positive and Negative Controls have no influence on the ability to drive and use machines.
Summary of safety profile
Soluprick Positive Control
Skin prick testing with Soluprick Positive Control (histamine dihydrochloride) will cause a local reaction with development of wheal and erythema with local itching after the test. In some cases (frequency not known), a slight pain at the application site may appear.
Soluprick Negative Control
In some cases (frequency not known), a slight pain at the application site may appear.
List of adverse drug reactions
Not applicable.
Description of selected adverse drug reactions
Paediatric population
Clinical safety data for the paediatric population <18 years of age are limited, however, clinical and post-marketing experience indicate that frequency, type and severity of adverse reactions in children are comparable to adults.
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 (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.
Soluprick Positive Control
Undesirable effects, in the form of exaggerated pharmacological effects, may occur with incorrect administration.
Soluprick Negative Control
Not applicable.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Histamine dihydrochloride. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Soluprick Controls. 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.
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